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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Dyslipoproteinemia
• Intervention / Treatment: Dietary supplement: Meal replacement (MR); Other: Control (C); Dietary supplement: Verum; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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) 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.	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)
ACTIVE_COMPARATOR: Verum group; Specific micronutrient composition with omega-3 fatty acids (capsules) Duration: 6-month weight maintenance phase (phase 3)	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)
PLACEBO_COMPARATOR: Placebo group; Placebo capsules Duration: 6-month weight maintenance phase (phase 3)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss (phase 1)	Intervention changes in body weight	3-month dietary intervention (from baseline I to 3rd month)
Total antioxidant capacity (phase 3)	Intervention changes in total antioxidant capacity	6-month dietary intervention (from baseline II to 12th month)
Fasting plasma cortisol concentration (phase 3)	Intervention changes in fasting plasma cortisol concentration	6-month dietary intervention (from baseline II to 12th month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative body fat (phase 1)	Intervention changes in relative body fat	3-month dietary intervention (from baseline I to 3rd month)
Relative body weight (phase 1)	Intervention changes in relative body weight	3-month dietary intervention (from baseline I to 3rd month)
Responder (weight loss > 5%) (phase 1)	Responder rate after 12 weeks	3-month dietary intervention (from baseline I to 3rd month)
Waist circumference (phase 1)	Intervention changes in waist circumference	3-month dietary intervention (from baseline I to 3rd month)
Total antioxidant capacity (phase 1)	Intervention changes in total antioxidant capacity	3-month dietary intervention (from baseline I to 3rd month)
Fasting plasma cortisol concentration (phase 1)	Intervention changes in fasting plasma cortisol concentration	3-month dietary intervention (from baseline I to 3rd month)
Relative body fat (phase 3)	Intervention changes in relative body fat	6-month dietary intervention (from baseline II to 12th month)
Relative body weight (phase 3)	Intervention changes in relative body weight	6-month dietary intervention (from baseline II to 12th month)
Responder (weight loss > 5%)	Responder rate after 12 months	12 months (from baseline I to 12th month)
Waist circumference (phase 3)	Intervention changes in waist circumference	6-month dietary intervention (from baseline II to 12th month)

Collaborators and Investigators

• Sponsor: Bonn Education Association for Dietetics r.A., Cologne, Germany
• Collaborators: FomMed HealthCare AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2004
• Primary Completion (ACTUAL): March 28, 2007
• Study Completion (ACTUAL): March 28, 2007

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Cardiometabolic risk; Weight Management Programs; Weight loss stabilization
• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Lipid Metabolism Disorders; Dyslipidemias; Overweight
• Other Study ID Numbers: BFD-01/FM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No