Clinical trial NCT03109834: Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women
Official title: Choice of Foods, Weight Loss and Metabolic Changes in Overweight Women Willing to Lose Weight With Dietary/Nutritional Therapy Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight and Obesity
Dyslipoproteinemia
Keywords: Weight Management Programs
Weight loss stabilization
Cardiometabolic risk
Lead sponsor: Bonn Education Association for Dietetics r.A., Cologne, Germany
Sponsor class: INDUSTRY
Collaborators: name: FomMed HealthCare AG
First posted: 2017-04-12
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel arms in weight loss phase and weight stabilization phase (1. randomization at baseline I); 2 parallel arms in weight maintanance phase (2. randomization at baseline II)
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Weight loss (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Total antioxidant capacity (phase 3)
timeFrame: 6-month dietary intervention (from baseline II to 12th month)
measure: Fasting plasma cortisol concentration (phase 3)
timeFrame: 6-month dietary intervention (from baseline II to 12th month)
Secondary outcomes:
measure: Relative body fat (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Relative body weight (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Responder (weight loss > 5%) (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Waist circumference (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Total antioxidant capacity (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Fasting plasma cortisol concentration (phase 1)
timeFrame: 3-month dietary intervention (from baseline I to 3rd month)
measure: Relative body fat (phase 3)
timeFrame: 6-month dietary intervention (from baseline II to 12th month)
measure: Relative body weight (phase 3)
timeFrame: 6-month dietary intervention (from baseline II to 12th month)
measure: Responder (weight loss > 5%)
timeFrame: 12 months (from baseline I to 12th month)
measure: Waist circumference (phase 3)
timeFrame: 6-month dietary intervention (from baseline II to 12th month)
Other outcomes:
Locations:
Study officials:
affiliation: Bonn Education Association for Dietetics r.A., Cologne, Germany
name: Christine Metzner, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.