Nutrition and Energy Restriction for Cancer Prevention (NCT02449148) | Clinical Trial Compass
CompletedNot Applicable
Nutrition and Energy Restriction for Cancer Prevention
Germany150 participantsStarted 2015-05
Plain-language summary
This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
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:
* Women and men aged 35 to 65 years
* Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 )
* German speaking
* Non- smoker
* Provision of written informed consent
Exclusion Criteria:
* Not able to understand and sign the informed consent form in person
* Already diagnosed diabetes
* HbA1c ≥ 6.5 % and/or fasting plasma glucose \> 125 mg/dl
* History of cancer within the past 10 years
* Risk of bleeding disorders (e.g. Marcumar intake)
* Current or history of eating disorders (bulimia, anorexia, binge-eating)
* Pregnant or lactating during the past 12 months
* Increased or decreased thyroid-stimulating hormone in baseline blood check
* Already diagnosed hepatic dysfunction and/or increased or decreased γ-GT, GPT and/or GOT in baseline blood check
* Already diagnosed kidney dysfunction and/or increased or decreased creatinine, urea and/or uric acid in baseline blood check
* Medications that might affect the endpoints of the study e.g. immunosuppressive medication (cortisol, antibody treatment), hormone replacement therapy, medication for fat metabolism (e.g. statine, fibrate)
* Participation in another intervention study shorter than three months ago
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
Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing
Timeframe: Assessments at baseline (week 0), and after the intervention phase (week 13)