Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women (NCT03109834) | Clinical Trial Compass
CompletedPhase 3
Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women
105 participantsStarted 2004-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight loss (phase 1)
Timeframe: 3-month dietary intervention (from baseline I to 3rd month)
2
Total antioxidant capacity (phase 3)
Timeframe: 6-month dietary intervention (from baseline II to 12th month)
3
Fasting plasma cortisol concentration (phase 3)
Timeframe: 6-month dietary intervention (from baseline II to 12th month)
Trial details
NCT IDNCT03109834
SponsorBonn Education Association for Dietetics r.A., Cologne, Germany