Clinically-Proven in Over 30 Studies

The Only Health & Weight Loss Shake with 30 Years of Research

The effectiveness of Almased has been extensively examined in peer-reviewed scientific studies by independent institutions worldwide for over 30 years. Almased is the only health and weight loss shake that has been scientifically researched in over 30 studies and actually improves your health. 

When you use Almased on a regular basis, you can feel confident knowing that you will be receiving numerous health benefits. Most wellness and supplement companies use studies that have been done on ingredients but not on their actual product to support health claims. And this unfortunately does not prove that their product actually works. What makes Almased different is - the health benefits shown on this page were done using Almased.

 

Almased Boosts Metabolism and Increases Fat Burn

Studies show Almased is superior for weight reduction and cardiovascular health compared to lifestyle intervention alone. Almased led to higher calorie expenditure, increased fat burning, and a reduced intake of carbohydrates and fats. This resulted in lower overall calorie and fat intake while promoting a positive protein balance. These findings show that Almased is effective in promoting fat loss compared to a conventional diet. Participants who used Almased experienced significantly more weight loss and fat mass reduction compared to those on a different diet. Furthermore, they exhibited improved metabolic markers and a reduced prevalence of metabolic syndrome. This underscores the potential of our product in mitigating the risks associated with diabetes. Even without notable changes in body composition, this combination reduced exercise-induced stress and inflammation, indicating that Almased can enhance exercise performance and metabolic function. Almased is beneficial for both premenopausal and postmenopausal women. In postmenopausal women, it led to substantial weight loss, primarily attributed to a reduction in fat mass. Additionally, it significantly improved various metabolic risk factors, reducing the prevalence of metabolic syndrome. 

Almased Unclogs Liver from Fat

Study on Almased's Effect on the Liver

Our research compares the outcomes of two interventions: a guided intensive lifestyle program and Almased, a soy protein-based meal replacement diet.

The study highlights the effectiveness of Almased, a meal replacement regimen as a viable approach for unclogging liver from fat. This intervention has demonstrated comparable outcomes to comprehensive lifestyle changes, including weight reduction, reduction in body and liver fat content, and improvements in markers of hepatic inflammation among people with clogged livers.

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Almased Clinical Studies: Metabolism & Weight Loss

Background: High-protein diets and total diet replacements are becoming increasingly popular for weight loss; however, further research is needed to elucidate their impact on the mechanisms involved in weight regulation.

Objective: The aim of this inpatient metabolic balance study was to compare the impact of a high-protein total diet replacement (HP-TDR) versus a control diet (CON) on select components of energy metabolism in healthy adults of both sexes.

Methods: The acute intervention was a randomized, controlled, crossover design with participants allocated to 2 isocaloric arms: 1) HP-TDR: consisted of a soy-potein nutritional supplement (Almased) mixed with olive oil and low-fat milk (35% carbohydrate, 40% protein, and 25% fat) 2) CON: 55% carbohydrate, 15% protein, and 30% fat. Participants received the prescribed diets for 32 h while inside a whole-body calorimetry unit (WBCU). The first dietary intervention randomly offered in the WBCU was designed to maintain energy balance and the second matched what was offered during the first stay. Energy expenditure, macronutrient oxidation rates and balances, and metabolic blood markers were assessed. Body composition was measured at baseline using DXA.

Results: Forty-three healthy, normal-weight adults (19 females and 24 males) were included. Compared with the CON diet, the HP-TDR produced higher total energy expenditure [(EE) 81 ± 82 kcal/d, P <0.001], protein and fat oxidation rates (38 ± 34 g/d, P <0.001; 8 ± 20 g/d, P = 0.013, respectively), and a lower carbohydrate oxidation rate (-38 ± 43 g/d, P <0.001). Moreover, a HP-TDR led to decreased energy (-112 ± 85 kcal/d; P <0.001), fat (-22 ± 20 g/d; P <0.001), and carbohydrate balances (-69 ± 44 g/d; P <0.001), and increased protein balance (90 ± 32 g/d; P <0.001).

Conclusions: Our primary findings were that a HP-TDR led to higher total EE, increased fat oxidation, and negative fat balance. These results suggest that a HP-TDR may promote fat loss compared with a conventional isocaloric diet. These trials were registered at clinicaltrials.gov as NCT02811276 and NCT03565510.

Link to Study: A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults - PubMed (nih.gov)

Download PDF: Almased Study on How Almased Increases Calorie Burn and Leads to Fat Reduction 

HTML Study Version - A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults

Aim: Our objective was to assess alterations in metabolic risk factors, body weight, fat mass and hormonal parameters following 6 weeks of lifestyle intervention with increased physical activity and either a meal-replacement regimen or a low calorie diet.

Research methods and procedures: 90 overweight or obese subjects (age 47 +/- 7.5 years, weight 90.6 +/- 11.3 kg, BMI 31.5 +/- 2.3) were included in this randomized controlled clinical trial. Subjects in the fat-restricted low-calorie-diet group (LCD-G; n = 30) received 2 dietary counseling sessions and instructions on how to increase physical activity. Subjects in the meal-replacement-diet group (MRD-G; n = 60) received the same lifestyle education and were instructed to replace 2 daily meals by a low-calorie high soy-protein drink.

Results: Subjects in the MRD-G lost significantly more weight (6.4 vs. 3.1 kg, p < 0.01) and fat mass (5.1 vs. 2.8 kg, p < 0.01) than the LCD-G. Most metabolic risk parameters were reduced in both the MRD-G and the LCD-G; however, subjects in the MRD-G showed a higher reduction in waist circumference (6.1 vs. 1.8 cm, p < 0.01) and a larger decrease in triglycerides (-19.6 vs. +12.5 mg/dl, p < 0.01). The prevalence of the metabolic syndrome was reduced in subjects in the MRD-G only (-12%, p < 0.05) compared to an unchanged risk score in the LCD-G. The reductions in leptin (18.2 vs. 6.97 ng/ml) and insulin (4.92 vs. 0.58 microU/ml) were only significant in the MRD-G (p < 0.01).

Discussion: Our data suggest that even over a short period of time, a meal-replacement diet is more effective in reducing metabolic risk factors, insulin, and leptin, and in improving anthropometric measures than a fat-restricted low-calorie diet.

Link to Study: Effect of meal replacement on metabolic risk factors in overweight and obese subjects - PubMed (nih.gov)
Download PDF: Almased Study on How Almased Reduces Metabolic Risk Factors

HTML Study Version - Effect of meal replacement on metabolic risk factors in overweight and obese subjects

Objective: To determine the changes in endurance capacity as well as in metabolic, hormonal and inflammatory markers induced by endurance training combined with a soy,protein based supplement.

Design: Randomized controlled study consisting of moderate endurance training without (GO) or with (G1) a soy protein based supplement (Almased).

Subjects: Two groups of 15 subjects (10 males and 5 females in each group): healthy sports students aged 23.6 +/- 1.9 years.

Measurements: Body composition (body mass (BM), body density (BD) by air displacement) and physical fitness (determined by treadmill ergometry) were measured at baseline and after 6 weeks of the intervention; changes in circulating metabolic and hormonal parameters (glucose, lactate, urea, uric acid, ammonia, cortisol, insulin, IGF-1), and exercise-induced stress and inflammatory markers (CK, LDH, myoglobin, hs-CRP, IL-6, IL-10, blood cell counts) were determined after the intervention period in afield test (11.5 km running on hilly ground).

Results: 30 participants completed the 6-week study; 28 students were able to perform the field test. No significant changes in BM and BD were noted after intervention with only slight increases in running performance and maximum aerobic capacity in the total group (2%, p=0.016). Subjects in the G1 group showed significant improvements in running velocity and lower lactate values following the intervention (-12%, p=0,003). In addition, the G1 group showed significantly lower differences in the exercise-induced increase of metabolic parameters (triglycerides, uric acid) and insulin in the post-exercise recovery period.

Conclusions: Our data suggest that moderate endurance training in combination with a soy-based protein supplement improves aerobic energy supply and metabolic function in healthy sports students, even without changes in body composition and without changes in the exercise-induced stress and inflammatory reaction.

Link to Study: A soy-based supplement alters energy metabolism but not the exercise-induced stress response - PubMed (nih.gov)

Download PDF: Almased alters energy metabolism

HTML Study Version - A soy-based supplement alters energy metabolism but not the exercise-induced stress response

Background: The present study examines changes in body weight, fat mass, metabolic and hormonal parameters in overweight and obese pre- and postmenopausal women who participated in a weight loss intervention.

Methods: Seventy-two subjects were included in the analysis of this single arm study (premenopausal: 22 women, age 43.7 +/- 6.4 years, BMI 31.0 +/- 2.4 kg/m2; postmenopausal: 50 women, age 58.2 +/- 5.1 years, BMI 32.9 +/- 3.7 kg/m2). Weight reduction was achieved by the use of a meal replacement (Almased) and fat-reduced diet. In addition, from week 6 to 24 participants attended a guided exercise program. Body composition was analyzed with the Bod Pod(R). Blood pressures were taken at every visit and blood was collected at baseline and closeout of the study to evaluate lipids, insulin, cortisol and leptin levels.

Results: BMI, fat mass, waist circumference, systolic blood pressure, triglycerides, glucose, leptin and cortisol were higher in the postmenopausal women at baseline. Both groups achieved a substantial and comparable weight loss (pre- vs. postmenopausal: 6.7 +/- 4.9 vs 6.7 +/- 4.4 kg; n.s.). However, in contrast to premenopausal women, weight loss in postmenopausal women was exclusively due to a reduction of fat mass (-5.3 +/- 5.1 vs -6.6 +/- 4.1 kg; p < 0.01). In premenopausal women 21% of weight loss was attributed to a reduction in lean body mass. Blood pressure, triglycerides, HDL-cholesterol, and glucose improved significantly only in postmenopausal women whereas total cholesterol and LDL-cholesterol were lowered significantly in both groups.

Conclusion: Both groups showed comparable weight loss and in postmenopausal women weight loss was associated with a pronounced improvement in metabolic risk factors thereby reducing the prevalence of metabolic syndrome.

Link to Study: Effect of a weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women - PubMed (nih.gov)

Download PDF: Almased study on effect of Almased on weight loss on measures and metabolisk risk factors in menopausal women

HTML Study Version - Effect of a weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women

Background: Non-alcoholic steatohepatitis (NASH) has become one of the leading causes of liver disease in the western world. In obese patients weight reduction is recommended. Up to now there are no specific guidelines for weight loss in order to reduce hepatic fat content.

Aim: To investigate the effects of a 24-wk guided lifestyle intervention program compared to a meal replacement regimen based on soy protein.

Methods: Twenty-six subjects with NASH participated in a randomized single-center study. They were randomly assigned to either meal replacement group (MR-G) with soy-yogurt-honey preparation (Almased) or to guided lifestyle change group (LC-G) with endurance activity and nutrition counselling. Serum alanine transaminase (ALT), aspartate transaminase (AST), lipid parameters, and adipokines were

measured. Liver fat content and lipid composition were determined by magnetic resonance imaging and magnetic resonance spectroscopy. Body fat mass and lean body mass were assessed using Bod Pod® device. Pre- and post-intervention monitoring of parameters was performed. Statistical analyses were conducted with SPSS software, results were expressed as median (interquartile range)

Results: Twenty-two subjects (MR-G, n = 11 and LC-G, n = 11) completed the study (9 women, 13 men; age 52.1 (15.0) years, body mass index (BMI) 32.3 (3.3) kg/m²). In both groups a significant weight loss was achieved (MR-G: -6.4 (3.6) kg, P < 0.01; LC-G: -9.1 (10.4) kg, P < 0.01). BMI dropped in both groups (MR-G: -2.3 (1.5) kg/m2, P = 0.003; LC-G: -3.0 (3.4) kg/m2, P = 0.006). Internal fat and hepatic lipid content were markedly reduced in both groups in comparable amount. There was a strong correlation between reduction in liver fat and decrease in ALT. Likewise, both groups showed an improvement in glycemic control and lipid profile. Changes in adipokines, particularly in adiponectin and leptin were closely related to intrahepatic lipid changes.

Conclusion: Comprehensive lifestyle intervention and meal replacement regimen have comparable effects on body and liver fat, as well as decrease in markers of hepatic inflammation among NASH patients.

Link to StudyComprehensive lifestyle intervention vs Almased (soy protein-based meal regimen) in non-alcoholic steatohepatitis

Download PDF: Liver Study - Effect of Almased compared to Comprehensive Lifestyle 

HTML Study Version - Comprehensive lifestyle intervention vs soy protein-based meal regimen in non-alcoholic steatohepatitis

Almased Reduces Weight and Cuts Hunger

Almased has shown remarkable benefits in weight management and improving overall health. When used during exercise, Almased increases fat burning and reduces post-exercise hunger. Furthermore, it has positive effects on specific metabolic markers, highlighting its potential as a valuable tool for those seeking to manage their weight effectively. One significant finding is the substantial reduction in leptin levels observed in the intervention group. Leptin plays a crucial role in weight management, and this reduction has been linked to sustained weight loss and fat reduction, demonstrating the effectiveness of our meal replacement-based lifestyle approach. Lastly, Almased has demonstrated its capacity to enhance fat metabolism and glycemic control, resulting in lower levels of ghrelin (a hunger hormone) and higher levels of PYY (a satiety hormone). These findings suggest that Almased, formulated with high-quality protein and a low glycemic index, can contribute significantly to weight reduction and an improvement in metabolic risk factors.

Almased Clinical Studies: Hunger & Appetite Regulation

Background: The aim of this study was to compare the impact of a high-protein meal replacement (HP-MR) versus a control (CON) breakfast on exercise metabolism.

Methods: In this acute, randomized controlled, cross-over study, participants were allocated into two isocaloric arms: (a) HP-MR: 30% carbohydrate, 43% protein, and 27% fat; (b) CON: 55% carbohydrate, 15% protein, and 30% fat. Following breakfast, participants performed a moderate-intensity aerobic exercise while inside a whole-body calorimetry unit. Energy expenditure, macronutrient oxidation, appetite sensations, and metabolic blood markers were assessed.

Results: Forty-three healthy, normal-weight adults (24 males) participated. Compared to the CON breakfast, the HP-MR produced higher fat oxidation (1.07 ± 0.33 g/session; p = 0.003) and lower carbohydrate oxidation (-2.32 ± 0.98 g/session; p = 0.023) and respiratory exchange ratio (-0.01 ± 0.00; p = 0.003) during exercise. After exercise, increases in hunger were lower during the HP-MR condition. Changes in blood markers from the fasting state to post-exercise during the HP-MR condition were greater for insulin, peptide tyrosine-tyrosine, and glucagon-like peptide 1, and lower for low-density lipoprotein cholesterol, triglyceride, and glycerol.

Conclusions: Our primary findings were that an HP-MR produced higher fat oxidation during the exercise session, suppression of hunger, and improved metabolic profile after it.

Link to Study: Consumption of a High-Protein Meal Replacement Leads to Higher Fat Oxidation, Suppression of Hunger, and Improved Metabolic Profile After an Exercise Session - PubMed (nih.gov)

Download PDF: Almased Study - Consuming Almased meal replacement leads to more fat oxidation, suppressed hunger, and improved metabolic health after exercise  

HTML Study Version - Consumption of a High-Protein Meal Replacement Leads to Higher Fat Oxidation, Suppression of Hunger, and Improved Metabolic Profile After an Exercise Session

Purpose: Dietary intake can affect energy homeostasis and influence body weight control. The aim of this study was to compare the impact of high-protein total diet replacement (HP-TDR) versus a control (CON) diet in the regulation of food intake and energy homeostasis in healthy, normal-weight adults.

Methods: In this acute randomized controlled, cross-over study, participants completed two isocaloric arms: a) HP-TDR: 35% carbohydrate, 40% protein, and 25% fat; b) CON: 55% carbohydrate, 15% protein, and 30% fat. The diets were provided for 32 h while inside a whole-body calorimetry unit. Appetite sensations, appetite-related hormones, and energy metabolism were assessed.

Results: Forty-three healthy, normal-weight adults (19 females) participated. Appetite sensations did not differ between diets (all p > 0.05). Compared to the CON diet, the change in fasting blood markers during the HP-TDR intervention was smaller for peptide tyrosine-tyrosine (PYY; - 18.9 ± 7.9 pg/mL, p = 0.02) and greater for leptin (1859 ± 652 pg/mL, p = 0.007). Moreover, postprandial levels of glucagon-like peptide 1 (1.62 ± 0.36 pM, p < 0.001) and PYY (31.37 ± 8.05 pg/mL, p < 0.001) were higher in the HP-TDR. Significant correlations were observed between energy balance and satiety (r = - 0.41, p = 0.007), and energy balance and PFC (r = 0.33, p = 0.033) in the HP-TDR.

Conclusion: Compared to the CON diet, the HP-TDR increased blood levels of anorexigenic hormones. Moreover, females and males responded differently to the intervention in terms of appetite sensations and appetite-related hormones.

Link to Study: A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults - PubMed (nih.gov)

Download PDF: Almased meal replacement diet alters regulation of food intake and energy balance

HTML Study Version - A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults

Purpose: Lifestyle interventions including meal replacement are suitable for prevention and treatment of obesity and type-2-diabetes.

Methods: Since leptin is involved in weight regulation, we hypothesised that a meal replacement-based lifestyle intervention would reduce leptin levels more effectively than lifestyle intervention alone. In the international, multicentre, randomised-controlled ACOORH-trial (Almased-Concept-against-Overweight-and-Obesity-and-Related- Health-Risk), overweight or obese participants with metabolic syndrome criteria (n = 463) were randomised into two groups and received telemonitoring devices and nutritional advice. The intervention group additionally used a protein-rich, low-glycaemic meal replacement. Data were collected at baseline, after 1, 3, 6, and 12 months. All datasets providing leptin data (n = 427) were included in this predefined subanalysis.

Results: Serum leptin levels significantly correlated with sex, body mass index, weight, and fat mass at baseline (p < 0.0001). Stronger leptin reduction has been observed in the intervention compared to the control group with the lowest levels after 1 month of intervention (estimated treatment difference −3.4 µg/L [1.4; 5.4] for females; −2.2 µg/L [1.2; 3.3] for males; p < 0.001 each) and was predictive for stronger reduction of body weight and fat mass (p < 0.001 each) over 12 months. Strongest weight loss was observed after 6 months (−5.9 ± 5.1 kg in females of the intervention group vs. −2.9 ± 4.9 kg in the control group (p < 0.0001); −6.8 ± 5.3 kg vs. −4.1 ± 4.4 kg (p = 0.003) in males) and in those participants with combined leptin and insulin decrease.

Conclusion: A meal replacement-based lifestyle intervention effectively reduces leptin which is predictive for long-term weight loss.

Link to Study: Early and Strong Leptin Reduction Is Predictive for Long-Term Weight Loss during High-Protein, Low-Glycaemic Meal Replacement-A Subanalysis of the Randomised-Controlled ACOORH Trial - PubMed (nih.gov)

Download PDF: Almased Study -Leptin Reduction Predictive for Long-Term Weight Loss 

HTML Study Version - Early and Strong Leptin Reduction Is Predictive for Long-Term Weight Loss during High-Protein, Low-Glycaemic Meal Replacement-A Subanalysis of the Randomised-Controlled ACOORH Trial

Objective: The present study investigated the postprandial glycemic and insulinemic responses, the levels of satiety-related proteins, and substrate use after a single dose of a meal replacement (MR) with a high soy protein content and a low glycemic index (GI). The results were compared with a standardized breakfast showing a high GI and a low protein content.

Methods: Eleven overweight or obese male subjects with the metabolic syndrome and insulin resistance were included in the study. In the morning, each subject consumed, in a randomized design, 65 g of a MR or an isocaloric standardized breakfast. Four hours after breakfast, all subjects consumed the same standardized lunch. Blood levels of glucose, insulin, ghrelin, protein YY(PYY), oxygen uptake, and carbon dioxide production were determined and the respiratory quotient and substrate use were calculated.

Results: The glycemic and insulinemic responses were considerably higher after the standardized breakfast. In addition, in these obese insulin-resistant subjects, the postprandial decease in fat oxidation was significantly less pronounced after intake of the MR. This effect was also detectable after lunch in terms of a second meal effect. Ghrelin levels were significantly lower 2 h after the intake of the MR and PYY levels tended higher.

Conclusion: Compared with the high GI/low-protein SB, a high soy protein MR with a low GI was associated with lower glycemia and insulinemia and relatively higher fat oxidation in the postprandial period. Together with a favorable course of appetite-regulating hormones, this could further help to explain the beneficial role of MR regimines high in soy protein for weight reduction and improvement of metabolic risk factors.

Link to Study: Fuel selection and appetite-regulating hormones after intake of a soy protein-based meal replacement - PubMed (nih.gov)

Download PDF: Almased meal replacement shakes effect on fuel selection and appetite hormones

HTML Study Version - Fuel selection and appetite-regulating hormones after intake of a soy protein-based meal replacement

Almased is Diabetes-Friendly

Almased proved highly effective in reducing body weight and supporting healthy glucose levels and insulin levels.

Individuals following the Almased diet were able to support healthy HbA1c levels, fasting blood glucose levels, blood pressure, and were able to reduce their body weight in just 12 weeks.

Remarkably, participants were able to support healthy blood sugar levels (HbA1c) for more than 52 weeks. 

 

Almased Clinical Studies: Blood Sugar Control

Objective: The aim of this study was to investigate the effect of a 6-wk intervention with either lifestyle intervention (increased physical activity and a low-calorie diet) or a meal replacement regimen on glycemic control in patients who are prediabetic and have impaired fasting glucose.

Methods: Forty-two overweight or obese men and women (age 54 ± 8 y; weight 95.1 ± 11.9 kg; body mass index [BMI] 32.8 ± 2.89 kg/m(2)) were included in this randomized controlled clinical trial. Patients in the lifestyle group (LS; n = 14) received dietary counseling sessions (fat-restricted low-calorie diet) and instructions on how to increase physical activity. Patients in the meal replacement group (MR; n = 28) were instructed to replace two daily meals with Almased, a low-calorie, high soy-protein drink with a low glycemic index.

Results: Both interventions resulted in a significant decrease in body weight and BMI, although the reduction was more pronounced (P < 0.05) in the MR group. In both groups, glucose concentrations decreased significantly (LS: -12 mg/dL, P < 0.01; MR: -11 mg/dL, P < 0.01), and mean glucose levels returned to the normal range. Insulin (LS: -1 μU/mg [not significant]; MR: -6.3 μU/mg, P < 0.01) and homeostasis model assessment of insulin resistance (HOMA-IR; LS -0.92, P < 0.01; MR: -2.1, P < 0.01) were also significantly lower following both interventions; again improvements were more pronounced in the MR group (insulin: P < 0.05; HOMA P < 0.01) CONCLUSION: It can be concluded that meal replacement is an effective intervention for rapid improvement of elevated fasting glucose and increased insulin concentrations, these being important biomarkers of the prediabetic state. The 6-wk intervention has shown that the effect of meal replacement on fasting blood glucose was comparable to the effect of lifestyle intervention. The alterations in BMI, insulin, and HOMA-IR were significantly more pronounced following the meal replacement regimen.

Link to Study: A meal replacement regimen improves blood glucose levels in prediabetic healthy individuals with impaired fasting glucose - PubMed (nih.gov)

Download PDF: Almased improves blood glucose levels 

HTML Study Version - A meal replacement regimen improves blood glucose levels in prediabetic healthy individuals with impaired fasting glucose

Objective: Lifestyle interventions are the foundation of treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced disease stages is unknown. We evaluated the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes.

Research design and methods: In this single-blind, active comparator, intervention study, patients with type 2 diabetes (with glycated hemoglobin [HbA1c] ≥7.5% [58.5 mmol/mol]), and BMI ≥27 kg/m2 and on ≥2 antidiabetes medications) were recruited in Germany and randomized 1:1 using an electronically generated random list and sealed envelopes into two parallel groups. The data analyst was blinded after assignment. The control group (n = 100) got weighing scales and step counters and remained in routine care. The TeLiPro group (n = 102) additionally received telemedical coaching including medical-mental motivation, Almased - a formula diet, and self-monitored blood glucose for 12 weeks. The primary end point was the estimated treatment difference in HbA1c reduction after 12 weeks. All available values per patient (n = 202) were analyzed. Analyses were also performed at 26 and 52 weeks of follow-up.

Results: HbA1c reduction was significantly higher in the TeLiPro group (mean ± SD -1.1 ± 1.2% vs. -0.2 ± 0.8%; P < 0.0001). The estimated treatment difference in the fully adjusted model was 0.8% (95% CI 1.1; 0.5) (P < 0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001). The same applies for secondary outcomes: weight (TeLiPro -6.2 ± 4.6 kg vs. control -1.0 ± 3.4 kg), BMI (-2.1 ± 1.5 kg/m2 vs. -0.3 ± 1.1 kg/m2), systolic blood pressure (-5.7 ± 15.3 mmHg vs. -1.6 ± 13.8 mmHg), 10-year cardiovascular disease risk, antidiabetes medication, and quality of life and eating behavior (P < 0.01 for all). The effects were maintained long-term. No adverse events were reported.

Conclusions: In advanced-stage type 2 diabetes, TeLiPro can improve glycemic control and may offer new options to avoid pharmacological intensification.

Link to Study: Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial - PubMed (nih.gov)

Download PDF Almased Study - Telemedical Lifestyle Intervention Program using Almased in Advanced Stages of Type 2 Diabetes

HTML Study Version - Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial

Background: Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. 

Methods: Type 2 diabetes patients were randomized into either a moderate group (M-group) with two Almased meal replacements/day (n = 160) or a stringent group (S-group) with three Almased meal replacements/day (n = 149) during the first week of intervention (1300⁻1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2⁻4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. 

Results: 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [-0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of -0.81% [-1.06; -0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. 

Conclusion: Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.

Link to Study: Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients - PubMed (nih.gov)

Download PDF: Almsaed Meal Replacement Therapy Improves Glycemic Control

HTML Study Version - Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients

Background: Lifestyle interventions have been shown to reverse hyperglycemia to normoglycemia. However, these effects are not long-lasting and are accompanied with high dropout rates. As formula diets have been shown to be simple in usage and effective in improving glycemic control, we hypothesised that adding a low-carbohydrate and energy deficit formula diet to a low-intensity lifestyle intervention is superior in reversing prediabetes compared with lifestyle intervention alone.

Methods & Results: In this predefined subanalysis of an international, multicenter randomised controlled trial (Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) study (ID DRKS00006811)), 141 persons with prediabetes were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 45) or a lifestyle intervention group accompanied with a formula diet (INT, n = 96). Both groups were equipped with telemonitoring devices. INT received, Almased, a low-carbohydrate formula diet substituting three meals/day (~1200 kcal/day) within the first week, two meals/day during week 2-4, and one meal/day during week 5-26 (1300-1500 kcal/day). Follow-up was performed after 52 weeks and 105 participants (75%, INT: n = 74; CON: n = 31) finished the 26-week intervention phase. Follow-up data after 52 weeks were available from 93 participants (66%, INT: n = 65; CON: n = 28). Compared with CON, significantly more INT participants converted to normoglycemia after 52 weeks (50% vs. 31%; p < 0.05). The risk reduction led to a number-needed-to-treat of 5.3 for INT.

Conclusion: Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention.

Link to Study: Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention-A 12-Month Subanalysis of the ACOORH Trial - PubMed (nih.gov)

Download PDF: Almased Study - Prediabetes Convension to Normoglycemia

HTML Study Version - Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention-A 12-Month Subanalysis of the ACOORH Trial

Background: Lifestyle interventions, including meal replacement, are effective in the prevention and treatment of type-2-diabetes and obesity.

Methods & Results: Since insulin is the key weight regulator, we hypothesised that the addition of meal replacement to a lifestyle intervention reduces insulin levels more effectively than lifestyle intervention alone. In the international multicentre randomised controlled ACOORH (Almased Concept against Overweight and Obesity and Related Health Risk) trial, overweight or obese persons who meet the criteria for metabolic syndrome (n = 463) were randomised into two groups. Both groups received nutritional advice focusing on carbohydrate restriction and the use of telemonitoring devices. The intervention group substituted all three main meals per day in week 1, two meals per day in weeks 2-4, and one meal per day in weeks 5-26 with, Almased, a protein-rich, low-glycaemic meal replacement. Data were collected at baseline and after 1, 3, 6 and 12 months. All datasets providing insulin data (n = 446) were included in this predefined subanalysis. Significantly higher reductions in insulin (-3.3 ± 8.7 µU/mL vs. -1.6 ± 9.8 µU/mL), weight (-6.1 ± 5.2 kg vs. -3.2 ± 4.6 kg), and inflammation markers were observed in the intervention group. Insulin reduction correlated with weight reduction and the highest amount of weight loss (-7.6 ± 4.9 kg) was observed in those participants with an insulin decrease > 2 µU/mL.

Conclusion: These results underline the potential for meal replacement-based lifestyle interventions in diabetes prevention, and measurement of insulin levels may serve as an indicator for adherence to carbohydrate restriction.

Link to Study: High-Protein, Low-Glycaemic Meal Replacement Decreases Fasting Insulin and Inflammation Markers-A 12-Month Subanalysis of the ACOORH Trial - PubMed (nih.gov)

Download PDF: 12-Month Study - Almased Decreases Fasting Insulin and Inflammation Markers

HTML Study Version - High-Protein, Low-Glycaemic Meal Replacement Decreases Fasting Insulin and Inflammation Markers-A 12-Month Subanalysis of the ACOORH Trial

Almased Supports Cardiovascular Health

In summary, these studies emphasize the effectiveness of Almased with lifestyle modifications in supporting cardiovascular health. Combining Almased with a lifestyle intervention can lead to better weight management and supporting cardiovascular risk factors. After 12 months, the Almased group achieved a more significant reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared to the control group. Additionally, they experienced positive changes in resting heart rate (HR) and pulse wave velocity (PWV) after 6 months.

Almased Clinical Studies: Cardiovascular Health

Background: As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone.

Methods: In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including, Almased, a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters.

Results: From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks.

Conclusions: A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.

Link to Study: Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial - PubMed (nih.gov)

Download PDF: Almased meal replacement reduces more weight than lifestyle intervention alone

HTML Study Version - Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial

Background: Low-caloric formula diets can improve hemodynamic parameters of patients with type 2 diabetes. We, therefore, hypothesized that persons with overweight or obesity can benefit from a high-protein, low-glycemic but moderate-caloric formula diet.

Methods: This post-hoc analysis of the Almased Concept against Overweight and Obesity and Related Health Risk- (ACOORH) trial investigated the impact of a lifestyle intervention combined with a formula diet (INT, n = 308) compared to a control group with lifestyle intervention alone (CON, n = 155) on hemodynamic parameters (systolic and diastolic blood pressure (SBP, DBP), resting heart rate (HR), and pulse wave velocity (PWV)) in high-risk individuals with prehypertension or hypertension. INT replaced meals during the first 6 months (1 week: 3 meals/day; 2−4 weeks: 2 meals/day; 5−26 weeks: 1 meal/day). Study duration was 12 months.

Results: From the starting cohort, 304 (68.3%, INT: n = 216; CON: n = 101) participants had a complete dataset. Compared to CON, INT significantly reduced more SBP (−7.3 mmHg 95% CI [−9.2; −5.3] vs. −3.3 mmHg [−5.9; −0.8], p < 0.049) and DBP (−3.7 mmHg [−4.9; −2.5] vs. −1.4 mmHg [−3.1; 0.2], p < 0.028) after 12 months. Compared to CON, INT showed a pronounced reduction in resting HR and PWV after 6 months but both lost significance after 12 months. Changes in SBP, DBP, and PWV were significantly associated positively with changes in body weight and fat mass (all p < 0.05) and resting HR correlated positively with fasting insulin (p < 0.001) after 12 months.

Conclusions:  Combining a lifestyle intervention with a high-protein and low-glycemic formula diet improves hemodynamic parameters to a greater extent than lifestyle intervention alone in high-risk individuals with overweight and obesity.

Link to Study: A High-Protein and Low-Glycemic Formula Diet Improves Blood Pressure and Other Hemodynamic Parameters in High-Risk Individuals - PubMed (nih.gov)

Download PDF: Almased Study - Improving Blood Pressure and Other Parameters

HTML Study Version - A High-Protein and Low-Glycemic Formula Diet Improves Blood Pressure and Other Hemodynamic Parameters in High-Risk Individuals

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