ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutrition and Energy Restriction for Cancer Prevention (HELENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02449148
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
University Hospital Heidelberg
Information provided by (Responsible Party):
Tilman Kuehn, German Cancer Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Visceral Obesity Weight Loss Metabolic Diseases Body Composition, Beneficial Other: Calorie Restriction Not Applicable

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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
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 %
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



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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), and after the maintenance phase (week 25) ]
  4. Changes in blood, leucocyte and urine 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

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


Locations
Germany
German Cancer Research Center
Heidelberg, Baden-Württemberg, Germany, D-69120
Sponsors and Collaborators
German Cancer Research Center
University Hospital Heidelberg
Investigators
Principal Investigator: Tilman Kühn, PhD German Cancer Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tilman Kuehn, Dr. Tilman Kühn, German Cancer Research Center
ClinicalTrials.gov Identifier: NCT02449148     History of Changes
Other Study ID Numbers: DKFZ Study_ID 670
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by Tilman Kuehn, German Cancer Research Center:
energy restriction
fasting
intermittent fast
cancer prevention
subcutaneous fat tissue gene expression

Additional relevant MeSH terms:
Obesity
Weight Loss
Metabolic Diseases
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes