Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women

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.

Conditions

• Overweight and Obesity
• Dyslipoproteinemia

Interventions

DIETARY_SUPPLEMENT

Meal replacement (MR)

MR-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d and was advised to replace two meals, i.e. breakfast and dinner, every day with two MR shakes, soups or bars and to prepare their own lunch during 3-month weight loss phase (phase 1). During 3-month weight stabilization phase (phase 2) MR-S group (MR group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The MR-S group was instructed to continue the implemented nutrition advice of weight loss phase. Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)

OTHER

Control (C)

During 3-month weight loss phase (phase 1) C-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d without MR for weight control. During 3-month weight stabilization (phase 2) phase C-S group (C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The C-S group was instructed to continue the implemented nutrition advice of weight loss phase. Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)

DIETARY_SUPPLEMENT

Verum

Verum: Specific micronutrient composition with omega-3 fatty acids (capsules) Verum group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 verum-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase (phase 3). Duration: 6 months (6.month / baseline II - 12.month)

OTHER

Placebo

Placebo group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 placebo-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase. Placebo contains no micronutrients and omega-3 fatty acids. Duration: 6 months (6.month / baseline II - 12.month)

Sponsors & Collaborators

• FomMed HealthCare AG

  collaborator UNKNOWN

• Bonn Education Association for Dietetics r.A., Cologne, Germany

  lead INDUSTRY

Principal Investigators

• Christine Metzner, Professor MD · Bonn Education Association for Dietetics r.A., Cologne, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-03-25

Primary Completion

2007-03-28

Completion

2007-03-28