Nutrition and Energy Restriction for Cancer Prevention (HELENA)
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ClinicalTrials.gov Identifier: NCT02449148 |
Recruitment Status :
Completed
First Posted : May 20, 2015
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Visceral Obesity Weight Loss Metabolic Diseases Body Composition, Beneficial | Other: Calorie Restriction | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Healthy Nutrition and Energy Restriction as Cancer Prevention Strategies: a Randomized Controlled Intervention Trial |
Study Start Date : | May 2015 |
Actual Primary Completion Date : | May 2017 |
Actual Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Intermittent Calorie Restriction
2 days per week fasting with 25 % energy intake and 5 days per week at 100% energy intake
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Other: Calorie Restriction
diet intervention to reduce the risk for obesity associated diseases
Other Name: weight loss trial; |
Experimental: Continuous Calorie Restriction
daily energy intake of 80 %
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Other: Calorie Restriction
diet intervention to reduce the risk for obesity associated diseases
Other Name: weight loss trial; |
No Intervention: Healthy Nutrition
general advice on healthy nutrition
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- Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing [ Time Frame: Assessments at baseline (week 0), and after the intervention phase (week 13) ]
- Changes in abdominal fat distribution pattern (visceral, subcutaneous, total adipose tissue) measured by magnetic resonance spectroscopy [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13),and after the follow-up phase (week 52) ]
- Changes in blood-based biomarkers, i.e. parameters of inflammation, adipokines, growth and hormonal factors, which have been shown to be associated with obesity-related chronic diseases before [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintenance phase (week 25), and after the maintenance phase (week 25) ]
- Changes in weight (kg) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in BMI (kg/m2) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in waist circumference (cm) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in hip circumference (cm) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in blood pressure (mm/Hg) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in pulse (bpm) [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]
- Changes in quality of life (as defined by changes in SF-12-derived scores) [ Time Frame: Assessments at baseline (week 0) and after the intervention phase (week 13) ]
- Changes in liver fat content measured by magnetic resonance spectroscopy [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13),and after the follow-up phase (week 52) ]
- Changes in the composition of the gut microbiota by taxonomic, functional, and comparative analysis of sequencing data [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]Exploratory Outcome
- Changes in blood metabolites, as measured by LC-MS/MS-based targeted and untargeted metabolomics tools [ Time Frame: Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52) ]Exploratory Outcome

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Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449148
Germany | |
German Cancer Research Center | |
Heidelberg, Baden-Württemberg, Germany, D-69120 |
Principal Investigator: | Tilman Kühn, PhD | German Cancer Research Center |
Responsible Party: | Tilman Kuehn, Dr. Tilman Kühn, German Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT02449148 |
Other Study ID Numbers: |
DKFZ Study_ID 670 |
First Posted: | May 20, 2015 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | December 2021 |
energy restriction fasting intermittent fast cancer prevention subcutaneous fat tissue gene expression |
Obesity Metabolic Diseases Obesity, Abdominal Weight Loss Overnutrition |
Nutrition Disorders Overweight Body Weight Body Weight Changes |