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

NCT ID: NCT03109834

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-25
• Study Completion Date: 2007-03-28

Brief 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.

Detailed 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.

Conditions

Overweight and Obesity; Dyslipoproteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meal replacement (MR) group

Energy-restricted modified diet with MR for weight control dietary supplement: MR shakes, soups or bars. Duration: 3-month weight loss phase (phase 1)

During weight stabilization phase (phase 2) MR counted to food choice option.

Group Type: ACTIVE_COMPARATOR

Meal replacement (MR)

Intervention Type: DIETARY_SUPPLEMENT

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)

Control (C) group

Energy-restricted modified diet without MR for weight control. Duration: 3-month weight loss phase (phase 1)

During 3-month weight stabilization phase (phase 2) MR counted to food choice option.

Group Type: OTHER

Control (C)

Intervention Type: OTHER

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)

Verum group

Specific micronutrient composition with omega-3 fatty acids (capsules)

Duration: 6-month weight maintenance phase (phase 3)

Group Type: ACTIVE_COMPARATOR

Verum

Intervention Type: DIETARY_SUPPLEMENT

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)

Placebo group

Placebo capsules

Duration: 6-month weight maintenance phase (phase 3)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

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)

Intervention Type: OTHER

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)

Intervention Type: DIETARY_SUPPLEMENT

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI: between 27.0 and 34.9 kg/m²
• One of the following blood lipids: total cholesterol ≥ 200 mg/dL, LDL-cholesterol ≥ 175 mg/dL, HDL-cholesterol ≤ 50 mg/dL, TG 150-400 mg/dL
• women, 18-60 years

Exclusion Criteria

• lactose or protein intolerance
• hypo- or hyperthyroidism
• pharmacological treatment of diabetes
• intake of vitamins or mineral supplements
• anticoagulants
• cardiac pacemaker
• contraindications to exercise

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

FomMed HealthCare AG

UNKNOWN

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Christine Metzner, Professor MD

Christine Metzner, Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Metzner, Professor MD

Role: PRINCIPAL_INVESTIGATOR

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

References

Metzner CE, Folberth-Vogele A, Bitterlich N, Lemperle M, Schafer S, Alteheld B, Stehle P, Siener R. Effect of a conventional energy-restricted modified diet with or without meal replacement on weight loss and cardiometabolic risk profile in overweight women. Nutr Metab (Lond). 2011 Sep 22;8(1):64. doi: 10.1186/1743-7075-8-64.

Reference Type: RESULT

PMID: 21939523 (View on PubMed)

Other Identifiers

BFD-01/FM-01

Identifier Type: -

Identifier Source: org_study_id