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Effect of Enriched Meal Replacements Protein on Weight Loss in Adults With Metabolic Syndrome (DPMS)
Randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65 years) with Metabolic Syndrome (MS). The sample size was calculated using a formula that compares two means, an alpha of 0.05 and a power of 95%. Based on these calculations, we established a baseline sample of 118 adults. For the diagnosis of MS, we used the classification from the International Diabetes Federation (IDF). 150 patients were screened; however, 32 were excluded because they did not meet the criteria. Doctors wrote down medical history; nutritionists conducted anthropometry (weight, height, and waist circumference); and nurses measured blood pressure and withdrew venous blood for determination of glucose, triglycerides, and HDL-cholesterol. After being randomly assigned to one of two groups, the control group received a diet with a lower protein content (0.8gr/kg body weight), and the intervention group received a diet with higher protein content (1.34gr/kg body weight). Both diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a caloric restriction of 500 calories less. For the intervention group, meal replacements were made with soy protein, and individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. Used as a substitute for food, the protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water. For both groups, the calorie density of the diet was adjusted for the baseline metabolic rate of each participant with a restriction of 500kcal/day.
Details
| Lead sponsor | Mexican National Institute of Public Health |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 118 |
| Start date | 2014-01 |
| Completion | 2015-03 |
Conditions
- Metabolic Syndrome X
- Weight Loss
Interventions
- High protein diet
- Low protein diet
Primary outcomes
- Changes in body weight (weight loss) — Six months
Changes in body weight will be evaluate through measures in baseline (month 0), month 3 (intermediate) and month 6 (final) by an Body weight Analyzer (model Avis 333)
Countries
Mexico