Clinical trial · Interventional
Nutrition and Energy Restriction for Cancer Prevention
Healthy Nutrition and Energy Restriction as Cancer Prevention Strategies: a Randomized Controlled Intervention Trial
NCT02449148CI-TRIAL-00055948HELENAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Composition, Beneficial | — | UNRESOLVED | — |
| Metabolic Diseases | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Visceral Obesity | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calorie Restriction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intermittent Calorie Restriction
- description
- 2 days per week fasting with 25 % energy intake and 5 days per week at 100% energy intake
- interventionNames
- Other: Calorie Restriction
- type
- EXPERIMENTAL
- label
- Continuous Calorie Restriction
- description
- daily energy intake of 80 %
- interventionNames
- Other: Calorie Restriction
- type
- NO_INTERVENTION
- label
- Healthy Nutrition
- description
- general advice on healthy nutrition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSowah SA, Milanese A, Schubel R, Wirbel J, Kartal E, Johnson TS, Hirche F, Grafetstatter M, Nonnenmacher T, Kirsten R, Lopez-Nogueroles M, Lahoz A, Schwarz KV, Okun JG, Ulrich CM, Nattenmuller J, von Eckardstein A, Muller D, Stangl GI, Kaaks R, Kuhn T, Zeller G. Calorie restriction improves metabolic state independently of gut microbiome composition: a randomized dietary intervention trial. Genome Med. 2022 Mar 14;14(1):30. doi: 10.1186/s13073-022-01030-0. PMID 35287713
- DERIVEDAllaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. PMID 33512717
- DERIVEDSchubel R, Nattenmuller J, Sookthai D, Nonnenmacher T, Graf ME, Riedl L, Schlett CL, von Stackelberg O, Johnson T, Nabers D, Kirsten R, Kratz M, Kauczor HU, Ulrich CM, Kaaks R, Kuhn T. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):933-945. doi: 10.1093/ajcn/nqy196. PMID 30475957