Overweight and ObesityPhase 3FM-01NCT03109834
Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women
A Phase 3 study testing Meal replacement (MR) and Verum in people with Overweight and Obesity and Dyslipoproteinemia, run by Bonn Education Association for Dietetics r.A., Cologne, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Overweight and Obesity, Dyslipoproteinemia
- What is being tested?
- Meal replacement (MR) and Verum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2004to 28 Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- pharmacological treatment of diabetes
- intake of vitamins or mineral supplements
- anticoagulants
- cardiac pacemaker
- contraindications to exercise
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Dyslipoproteinemia
- Being tested
- Meal replacement (MR), Control (C), Verum, Placebo
- Keywords
- Weight Management Programs, Weight loss stabilization, Cardiometabolic risk
- Medical subject headings
- Overweight, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
VerumDietary 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)
PlaceboOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (C) |
| Verum group | Active comparator | Specific micronutrient composition with omega-3 fatty acids (capsules)
Duration: 6-month weight maintenance phase (phase 3) Receives: Dietary Supplement: Verum |
| Placebo group | Placebo comparator | Placebo capsules
Duration: 6-month weight maintenance phase (phase 3) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (phase 1)
Intervention changes in body weight
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Total antioxidant capacity (phase 3)
Intervention changes in total antioxidant capacity
Measured: 6-month dietary intervention (from baseline II to 12th month)
Fasting plasma cortisol concentration (phase 3)
Intervention changes in fasting plasma cortisol concentration
Measured: 6-month dietary intervention (from baseline II to 12th month)
Secondary outcomes (10)
Relative body fat (phase 1)
Intervention changes in relative body fat
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Relative body weight (phase 1)
Intervention changes in relative body weight
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Responder (weight loss > 5%) (phase 1)
Responder rate after 12 weeks
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Waist circumference (phase 1)
Intervention changes in waist circumference
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Total antioxidant capacity (phase 1)
Intervention changes in total antioxidant capacity
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Fasting plasma cortisol concentration (phase 1)
Intervention changes in fasting plasma cortisol concentration
Measured: 3-month dietary intervention (from baseline I to 3rd month)
Relative body fat (phase 3)
Intervention changes in relative body fat
Measured: 6-month dietary intervention (from baseline II to 12th month)
Relative body weight (phase 3)
Intervention changes in relative body weight
Measured: 6-month dietary intervention (from baseline II to 12th month)
Responder (weight loss > 5%)
Responder rate after 12 months
Measured: 12 months (from baseline I to 12th month)
Waist circumference (phase 3)
Intervention changes in waist circumference
Measured: 6-month dietary intervention (from baseline II to 12th month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start25 Mar 2004
- Primary completion28 Mar 2007
- Study completion28 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonn Education Association for Dietetics r.A., Cologne, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FomMed HealthCare AG
- Responsible party
- Principal investigator, Christine Metzner, Professor MD, Bonn Education Association for Dietetics r.A., Cologne, Germany
- Investigators
- Christine Metzner, Professor MD, Principal investigator, Bonn Education Association for Dietetics r.A., Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109834
- Sponsor's protocol ID
- BFD-01/FM-01
- Acronym
- FM-01
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21939523
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Foods, Weight Loss and Metabolic Changes in Overweight Women Willing to Lose Weight With Dietary/Nutritional Therapy Intervention
- ClinicalTrials.gov ID
- NCT03109834
- Acronym / sponsor ID
- FM-01 / BFD-01/FM-01
- Conditions
- Overweight and Obesity, Dyslipoproteinemia
- Keywords
- Weight Management Programs, Weight loss stabilization, Cardiometabolic risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bonn Education Association for Dietetics r.A., Cologne, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- FomMed HealthCare AG
- Study start
- 25 Mar 2004 (actual)
- Primary completion
- 28 Mar 2007 (actual)
- Study completion
- 28 Mar 2007 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Meal replacement (MR) group | Active comparator | Dietary Supplement: Meal replacement (MR)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. |
| Control (C) group | Other | Other: Control (C)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. |
| Verum group | Active comparator | Dietary Supplement: VerumSpecific micronutrient composition with omega-3 fatty acids (capsules) Duration: 6-month weight maintenance phase (phase 3) |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo capsules Duration: 6-month weight maintenance phase (phase 3) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
- lactose or protein intolerance
- hypo- or hyperthyroidism
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Dietary supplement | Meal replacement (MR) group |
| 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) | Other | Control (C) group |
| VerumVerum: 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) | Dietary supplement | Verum group |
| PlaceboPlacebo 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) | Other | Placebo group |
Primary outcome
Weight loss (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Intervention changes in body weight
Total antioxidant capacity (phase 3)
Time frame: 6-month dietary intervention (from baseline II to 12th month)
Intervention changes in total antioxidant capacity
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
10 secondary outcomes
Relative body fat (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Relative body weight (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Responder (weight loss > 5%) (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Waist circumference (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Total antioxidant capacity (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Fasting plasma cortisol concentration (phase 1)
Time frame: 3-month dietary intervention (from baseline I to 3rd month)
Relative body fat (phase 3)
Time frame: 6-month dietary intervention (from baseline II to 12th month)
Relative body weight (phase 3)
Time frame: 6-month dietary intervention (from baseline II to 12th month)
Responder (weight loss > 5%)
Time frame: 12 months (from baseline I to 12th month)
Waist circumference (phase 3)
Time frame: 6-month dietary intervention (from baseline II to 12th month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Results publication: PubMed 21939523Metzner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Metzner, Professor MD principal investigator
Bonn Education Association for Dietetics r.A., Cologne, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meal replacement (MR) and Verum in people with Overweight and Obesity and Dyslipoproteinemia, run by Bonn Education Association for Dietetics r.A., Cologne, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (phase 1) (time frame: 3-month dietary intervention (from baseline I to 3rd month)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.