Highlights:

  • 2014: Body weight and glucose control in overweight subjects
  • 2017: Reductions in HbA1c, fasting blood glucose, body weight, BMI, blood pressure, cardiovascular risk factors and diabetes medications
  • 2018: improvements in HbA1c, fasting blood glucose, blood pressure and weight 
  • 2020: Diabetes and conversion to normoglycemia 

With over 30 years of scientific research behind it, the Almased diet is clinically-proven to support healthy blood sugar levels for long-term glycemic control and provide a positive impact on HbA1c in adults with diabetes. 

Here we review four out of many Almased studies that have shown remarkable benefits according to multiple parameters of metabolic and glucose health, including glycated hemoglobin A1c (HbA1c). 

Pre-Diabetes 

In 2014, Daniel König and a group of researchers from the University of Freiburg looked at 6 weeks of a diet and lifestyle intervention (increased physical activity and a low-calorie diet) or a meal replacement regimen using Almased on glycemic control in patients who were prediabetic and had impaired fasting glucose. 

Forty-two overweight or obese men and women (age 54 ± 8 y; body mass index [BMI] 32.8 ± 2.89 kg/m2) 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 a low-calorie, high soy-protein drink with a low glycemic index — Almased. 

African American man in supermarket produce aisle smiling

Results? Both interventions resulted in a significant decrease in body weight and BMI, although the reduction was more pronounced (P < 0.05) in the Almased group. In both groups, glucose concentrations decreased significantly (LS: -12 mg/dL, P < 0.01; Almased: -11 mg/dL, P < 0.01), and mean glucose levels returned to the normal range. 

The study showed that meal replacement with Almased was an effective intervention for rapid improvement of elevated fasting glucose and increased insulin concentrations, important biomarkers of prediabetes. 

The beneficial alterations in BMI, insulin, and HOMA-IR (homeostatic model assessment for insulin resistance) were significantly more pronounced following the Almased regimen. 

Type 2 Diabetes 

TeLiPro Study 

In a 2017 study by Kerstin Kempf and a group of German researchers, a 12-week telemedical lifestyle intervention (TeLiPro) was carried out in patients with advanced type 2 diabetes. 

It included weekly phone calls by trained diabetes educators who talked about diet, exercise and options for overall lifestyle changes. 

For the first 12 weeks, the TeLiPro group also received Almased in place of three meals a day for the first week, two meals a day for weeks 2 to 4, then one meal a day for weeks 5 to 12. 

After the intervention phase, a highly significant reduction of mean HbA1c was seen in the TeLiPro group. At 12 weeks, mean HbA1c was reduced by 1.1 ± 1.2% (from 8.4% [68.3 mmol/mol] ± 1.3% to 7.3% [56.3 mmol/mol] ± 1.1%) in the TeLiPro group (P < 0.0001) 

In this group, there were also significant reductions in fasting blood glucose, body weight, body mass index, blood pressure, cardiovascular risk factors, and requirements for diabetes medications — a 20% lower need for medications and a nearly 50% reduction in insulin needs.

These improvements were even seen after 52 weeks of follow-up.

Types of diabetes 1 

Poorly Controlled Type 2 Diabetes 

In a 2018 study, also by Kerstin Kempf and colleagues, patients with type 2 diabetes were randomized into either a moderate group (M-group) that had two meal replacements with Almased per day (n = 160) or a “stringent group” (S-group) that had three meal replacements/day with Almased daily (n = 149) during the first week of intervention (1300–1500 kcal/day).  

Afterwards, both groups received a low-carbohydrate lunch based on individual adaption according to self-monitoring of blood glucose SMBG during weeks 2 to 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 with Almased until the 52-week follow-up. In addition, 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? In total, 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) completed the whole intervention after 52 weeks. 

The three-meal-a day group (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. 

Both Almased groups achieved improvements in HbA1c, fasting blood glucose, blood pressure and weight within 12 weeks.  

Of special note, the clinically relevant Hba1c reduction was seen in the “stringent” group up to 52 weeks, even though this group shifted to one Almased meal replacement per day for the last 51 weeks. 

This long-term reduction in HbA1c that persists long after the initial week of full meal replacements suggests that Almased may help to beneficially “reset” certain aspects of metabolism. 

Overweight and Diabetes 

ACOORH Study 

In 2020, in a subanalysis of a randomized, controlled international multicenter trial (Almased Concept against Overweight and Obesity and Related Health Risk or ACOORH), 141 adults with diabetes were randomized into either a control group (CON) with lifestyle intervention only or a lifestyle intervention group (INT) that included Almased.  

In the INT group, Almased replaced three meals per day for the first week, two meals per day during weeks 2 to 4, and one meal per day for weeks 5 to 26. Follow-up was performed after 52 weeks.

Woman celebrating weight loss on a medical weight scale 1

The significant difference in weight reduction in the INT group was accompanied by improvements in BMI, fat mass, waist circumference, fat-free mass, LDL-C (all p < 0.01), HbA1c, and total cholesterol (both p < 0.05) after 12 weeks of intervention compared with CON in the between-group analysis. 

After the 26 weeks, significantly more patients taking Almased converted to normoglycemia by the 52-week follow-up than did patients who had the lifestyle intervention alone.

Sources

  1. König D, Kookhan S, Schaffner D, Deibert P, Berg A. A meal replacement regimen improves blood glucose levels in prediabetic healthy individuals with impaired fasting glucose. Nutrition. 2014 Nov-Dec;30(11-12):1306-9. doi: 10.1016/j.nut.2014.03.014 https://www.sciencedirect.com/science/article/abs/pii/S0899900714001488?via%3Dihub
  2. Kempf K, Altpeter B, Berger J, Reuß O, Fuchs M, Schneider M, Gärtner B, Niedermeier K, Martin S. Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in advanced stages of type 2 diabetes: A randomized controlled trial. Diabetes Care. 2017 Jul;40(7):863-871. doi: 10.2337/dc17-0303 https://care.diabetesjournals.org/content/40/7/863
  3. Kempf K, Röhling M, Niedermeier K, Gärtner B, Martin S. Individualized meal replacement therapy improves clinically relevant long-term glycemic control in poorly controlled type 2 diabetes patients. Nutrients. 2018 Aug 4;10(8):1022. doi: 10.3390/nu10081022 https://www.mdpi.com/2072-6643/10/8/1022/htm
  4. Röhling M, Kempf K, Banzer W, Berg A, Braumann KM, Tan S, Halle M, McCarthy D, Pinget M, Predel HG, Scholze J, Toplak H, Martin S, ACOORH Study Group. 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. Nutrients. 2020 Jul 7;12(7):2022. doi: 10.3390/nu12072022 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400892/