Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women — FM-01  

Overweight and Obesity Clinical Trial

Official title: Choice of Foods, Weight Loss and Metabolic Changes in Overweight Women Willing to Lose Weight With Dietary/Nutritional Therapy Intervention

Status Completed

Clinical Trial Summary

Aim of this prospective randomized study was to evaluate whether a diet with meal replacements can be as effective as a conventional energy-restricted modified diet on weight loss, body composition and cardiometabolic risk profile in overweight women. Moreover, the impact of these two different weight management strategies was observed on cardiometabolic risk profile after a self-directed weight stabilization phase following the weight loss phase. After that, the effect of a specific micronutrient composition with omega-3 fatty acids versus placebo on cardiometabolic risk was observed during a following phase of weight loss maintenance.

Clinical Trial Description

Abdominal obesity, atherogenic dyslipidemia and hypertension are essential risk factors for cardiovascular diseases. Several studies showed favorable effects of weight loss in overweight subjects on cardiometabolic risk profile.

The study was divided into a 3-month weight loss phase (phase 1), a subsequent 3-month phase of weight stabilization (phase 2) and a 6-month phase of weight loss maintenance (phase 3).

For a total of 6 months subjects were randomly assigned to the meal replacement (MR) or control (C) group at baseline I.

During weight loss phase both dietary intervention groups followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d. The MR-WL group (MR group during weight loss phase) was advised to replace two of three meals every day with meal replacements. The C-WL group (C group during weight loss phase) was advised to follow a conventional energy-restricted modified diet with 15-20% of energy intake in the form of protein, 50-55% of energy intake in the form of carbohydrates and 30% of energy intake in the form of fat. All participants attended ten group training sessions for nutrition education.

During weight stabilization phase all women of MR-S and C-S group (MR and C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. However, the MR-S and C-S group were instructed to continue the implemented nutrition advice of weight loss phase.

At the beginning of weight loss maintenance phase (baseline II) women were randomly assigned to the verum (specific micronutrient composition with omega-3 fatty acids) group or placebo group. Both groups were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods.

All women participated in an exercise program (fitness walking) on 1-2 days per week during all three phases of the study for a total of 12 months. ;

Related Conditions & MeSH terms

• Dyslipidemias
• Dyslipoproteinemia
• Overweight
• Overweight and Obesity

• NCT number: NCT03109834
• Study type: Interventional
• Source: Bonn Education Association for Dietetics r.A., Cologne, Germany
• Status: Completed
• Phase: Phase 3
• Start date: March 25, 2004
• Completion date: March 28, 2007