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Completed

NCT Number: NCT03109834

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Dyslipidemias Dyslipoproteinemia Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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)

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)

Primary outcomes

  1. Weight loss (phase 1)

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

    Intervention changes in body weight

  2. Total antioxidant capacity (phase 3)

    Time frame: 6-month dietary intervention (from baseline II to 12th month)

    Intervention changes in total antioxidant capacity

  3. Fasting plasma cortisol concentration (phase 3)

    Time frame: 6-month dietary intervention (from baseline II to 12th month)

    Intervention changes in fasting plasma cortisol concentration

Secondary outcomes

  1. Relative body fat (phase 1)

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

    Intervention changes in relative body fat

  2. Relative body weight (phase 1)

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

    Intervention changes in relative body weight

  3. Responder (weight loss > 5%) (phase 1)

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

    Responder rate after 12 weeks

  4. Waist circumference (phase 1)

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

    Intervention changes in waist circumference

  5. Total antioxidant capacity (phase 1)

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

    Intervention changes in total antioxidant capacity

  6. Fasting plasma cortisol concentration (phase 1)

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

    Intervention changes in fasting plasma cortisol concentration

  7. Relative body fat (phase 3)

    Time frame: 6-month dietary intervention (from baseline II to 12th month)

    Intervention changes in relative body fat

  8. Relative body weight (phase 3)

    Time frame: 6-month dietary intervention (from baseline II to 12th month)

    Intervention changes in relative body weight

  9. Responder (weight loss > 5%)

    Time frame: 12 months (from baseline I to 12th month)

    Responder rate after 12 months

  10. Waist circumference (phase 3)

    Time frame: 6-month dietary intervention (from baseline II to 12th month)

    Intervention changes in waist circumference

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • FomMed HealthCare AG

Registry information

Official study title

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

Acronym: FM-01

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2017
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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