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 range35 Years – 65 Years
SexALL
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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
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)