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

NCT03109834 | Completed Phase 3

• 1 other identifier: BFD-01/FM-01
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity; Dyslipoproteinemia

Keywords

Weight Management Programs; Weight loss stabilization; Cardiometabolic risk

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Relative body fat (phase 1)

  3-month dietary intervention (from baseline I to 3rd month)

• Relative body weight (phase 1)

  3-month dietary intervention (from baseline I to 3rd month)

• Responder (weight loss > 5%) (phase 1)

  3-month dietary intervention (from baseline I to 3rd month)

• Waist circumference (phase 1)

  3-month dietary intervention (from baseline I to 3rd month)

• Total antioxidant capacity (phase 1)

  3-month dietary intervention (from baseline I to 3rd month)

Study Arms (4)

Meal replacement (MR) group

ACTIVE COMPARATOR

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)

Control (C) group

OTHER

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)

Verum group

ACTIVE COMPARATOR

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

Dietary Supplement: Verum

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Meal replacement (MR) 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)

Meal replacement (MR) group

Control (C) 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)

Control (C) group

Verum 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)

Verum group

Placebo 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)

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 21939523 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Dyslipidemias

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Christine Metzner, Professor MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christine Metzner, Professor MD

Model Details: 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)

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 12, 2017
• Study Start: March 25, 2004
• Primary Completion: March 28, 2007
• Study Completion: March 28, 2007
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share