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

Bonn Education Association for Dietetics

Status and phase: Completed; Phase 3

Conditions: Dyslipoproteinemia; Overweight and Obesity

Treatments: Other: Placebo; Dietary Supplement: Meal replacement (MR); Dietary Supplement: Verum; Other: Control (C)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03109834

BFD-01/FM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Specific 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 4 patient groups, including a placebo group

Meal replacement (MR) group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Meal replacement (MR)

Control (C) group

Other group

Description:

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.

Treatment:

Other: Control (C)

Verum group

Active Comparator group

Description:

Specific micronutrient composition with omega-3 fatty acids (capsules) Duration: 6-month weight maintenance phase (phase 3)

Treatment:

Dietary Supplement: Verum

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo