The Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) trial is an international multicenter randomized and controlled intervention study comparing the effects of an Almased meal-replacement-based lifestyle intervention vs. lifestyle intervention alone in overweight or obese adults with risk factors for metabolic syndrome.
In this study, participants were randomized using a 1:2 allocation ratio into either a lifestyle intervention control group (n = 155) or a meal replacement-based lifestyle intervention group (n = 308).1
Twenty-six weeks of an intensive lifestyle intervention were followed by a moderate intensive follow-up phase until week 52.
Individuals were eligible if they were 21 to 65 years old with a body mass index (BMI) of 27–35 kg/m2 and/or a waist circumference of ≥ 34.6 inches or ≥ 40.15 inches (females and males, respectively), and had at least one of the following criteria of metabolic syndrome: (a) fasting blood glucose (FBG) 100–125 mg/dL, (b) triglycerides 150–400 mg/dL, (c) high-density lipoprotein (HDL) cholesterol < 40 mg/dL, or (d) untreated systolic blood pressure of 140–160 mmHg or diastolic blood pressure of 90–100 mmHg or use of antihypertensive medication.
People in both groups visited the study center at baseline as well as after 4, 12, 26 and 52 weeks. Participants received nutrition counselling at the study visits and were instructed to increase physical activity. Additionally, both groups were equipped with telemetric scales and pedometers that automatically transferred data into a personalized online portal. During study visits, acquired data (e.g., steps, weight, diet protocols) were discussed and participants were motivated to achieve their individual goals (e.g., weight reduction, healthy lifestyle changes).
Participants of the intervention group additionally received a high-protein, low-glycemic meal replacement (Almased) during the first 26 weeks. In brief, in the first week all three main meals were replaced, then in weeks 2–4 only breakfast and dinner, and afterward only dinner was replaced until week 26. An accompanying manual included information about the preparation of the meal replacement as well as general facts about low-carbohydrate meals and their influence on blood glucose and insulin levels, hunger, and weight loss.
In this subanalysis of the ACOORH trial, the authors primarily focused on fasting insulin as insulin not only mediates glucose uptake from the blood into the cells but also has further physiological regulatory functions.
During the intervention, fasting insulin levels significantly decreased in both groups (within group comparison: p < 0.0001 at all time points in the intervention group and p < 0.05 in the control group), although insulin reduction was significantly higher in the intervention group.
In parallel, significant weight reduction was observed in both groups (within group comparisons for both: p < 0.0001 at all time points) but also showed a higher reduction in the intervention group. The highest improvements in insulin levels (−3.3 ± 8.7 µU/mL in the intervention group vs −1.6 ± 9.8 µU/mL in the control group) and body weight (−13.4 pounds vs. −7 pounds) were observed after six months at the end of the intervention phase.
There was a trend toward a reduction of the proinflammatory inflammation markers CRP and IL-6 in the intervention group following the intervention, peaking after six months, while the control group showed no consistent change over time.
A significant correlation between the reduction of fasting insulin and body weight could be observed consequently at all observation times throughout the study. The tertile analyses further demonstrated that the participants with insulin reduction also achieved the highest weight reduction over the course of the study.
According to the authors, the advantage of this study compare to intensive long-term lifestyle programs is that the meal composition is clear and easy to use while also containing nutrients, vitamins, minerals, and trace elements. In addition, it has been shown that meal replacement can actively reduce insulin levels and these effects can be already seen after one week.
In this study, participants who only used Almased for a short time had a more significant weight reduction compared to those from the control group. In other words, the participants who only used Almased for 4 weeks lost as much weight after one year as those in the control group who carried out the lifestyle intervention without Almased throughout the entire study phase.
Significantly higher reductions in insulin, weight and inflammation markers were observed in the intervention group. Insulin reductions correlated with weight reduction, with the highest amount of weight loss observed in those participants with an insulin decrease > 2 µU/mL.
Previously published data demonstrated significantly higher success in weight reduction in the meal replacement intervention group compared to the control group with an estimated treatment difference (ETD) −3.2 kg (−4.0; −2.5) (p < 0.001).2 A previous subanalysis of participants with prediabetes at baseline showed that reconversion to normoglycemia was significantly more often achieved in the intervention group (50% vs. 31%; p < 0.05).3
The authors wrote: “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.”
“Meal replacement-based lifestyle interventions should therefore not only be used in the treatment of manifested type 2 diabetes but also in primary prevention, while insulin measurements might be used to monitor for compliance in carbohydrate restriction,” the authors concluded.