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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03109834
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
FomMed HealthCare AG
Information provided by (Responsible Party):
Christine Metzner, Professor MD, Bonn Education Association for Dietetics r.A., Cologne, Germany

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dyslipoproteinemia Dietary Supplement: Meal replacement (MR) Other: Control (C) Dietary Supplement: Verum Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Choice of Foods, Weight Loss and Metabolic Changes in Overweight Women Willing to Lose Weight With Dietary/Nutritional Therapy Intervention
Actual Study Start Date : March 25, 2004
Actual Primary Completion Date : March 28, 2007
Actual Study Completion Date : March 28, 2007

Resource links provided by the National Library of Medicine


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)


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)





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109834


Sponsors and Collaborators
Bonn Education Association for Dietetics r.A., Cologne, Germany
FomMed HealthCare AG
Investigators
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Principal Investigator: Christine Metzner, Professor MD Bonn Education Association for Dietetics r.A., Cologne, Germany
Publications of Results:
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Responsible Party: Christine Metzner, Professor MD, Bonn Education Association for Dietetics r.A., Cologne, Germany
ClinicalTrials.gov Identifier: NCT03109834    
Other Study ID Numbers: BFD-01/FM-01
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Metzner, Professor MD, Bonn Education Association for Dietetics r.A., Cologne, Germany:
Weight Management Programs
Weight loss stabilization
Cardiometabolic risk
Additional relevant MeSH terms:
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Dyslipidemias
Overweight
Body Weight
Lipid Metabolism Disorders
Metabolic Diseases