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Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer (1072)

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: NCT00467220
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 26, 2007
First Posted Date  ICMJE April 30, 2007
Last Update Posted Date January 22, 2020
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2011)
Adipose tissue dynamics [ Time Frame: 12 weeks ]
Parameters measured will include adipose tissue dynamics (triglyceride turnover, lipolysis, de novo lipogenesis, adipose cell proliferation), adipose tissue morphology (cell size and number), adipose tissue hormone levels (adiponectin, leptin), skin turnover (keratin dynamics), T-lymphocyte proliferation, as well as plasma lipid and lipoprotein, homocysteine, and C-reactive protein levels.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer
Official Title  ICMJE Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer
Brief Summary The purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.
Detailed Description Overweight individuals are at greater risk for certain chronic diseases such as cardiovascular disease and cancer when compared to those who are normal weight. Dietary restriction has been shown to lower the risk of these chronic diseases in overweight human subjects as well as in normal weight rodents. The majority of studies examining dietary restriction protocols in rodents or humans implement daily calorie restriction (CR), i.e. where the amount of energy consumed is decreased by a certain percentage every day. Another dietary restriction regimen employed, although less commonly, is intermittent caloric restriction, or alternate-day fasting (ADF), i.e. where food is available ad-librium every other day, alternating with a partial or complete caloric restriction day. Recent findings suggest that ADF may modulate certain indices of disease risk to a similar extent as daily CR in animal models. The effect of ADF regimens in comparison with CR regimens on disease risk has yet to be performed in human subjects, however. ADF protocols need not result in weight loss, and would therefore be appropriate for non-obese individuals. Accumulating evidence suggest that adipose tissue may play a role in modulating chronic disease risk by releasing substrates, such as fatty acids, or a variety of hormones, including adiponectin and leptin. The effect of ADF and CR on adipose tissue metabolism and hormone release remains unclear. Accordingly, the aim of the present study is to compare ADF regimes to CR for their effects on risk factors for cardiovascular disease and cancer and their effects on adipose tissue metabolism and hormone secretion, in normal weight to modestly overweight (BMI 22-27 kg/m2) human subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Moderately Overweight Individuals
Intervention  ICMJE Behavioral: calorie restriction
Subjects in the "calorie restriction" arm and the "alternate day fasting" arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction.
Study Arms  ICMJE
  • No Intervention: Control
    Subjects will follow all study tasks but will not be required to follow a calorie-restricted meal plan.
  • Alternate Day Fasting Arm
    Subjects in this arm will be asked to alternate between one day of eating as they wish versus one day on a calorie-restricted meal plan. Subjects will follow this alternating meal plan for 3 months.
    Intervention: Behavioral: calorie restriction
  • Calorie Restriction
    Subjects in this arm will be asked to follow a calorie-restricted meal plan, daily, for three months.
    Intervention: Behavioral: calorie restriction
Publications * Allaf 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
24
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2007)
40
Actual Study Completion Date  ICMJE December 17, 2015
Actual Primary Completion Date December 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female; body mass index (BMI) between 20-30 kg/m2;
  • Age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week);
  • Weight stable for >3 months prior to the beginning of the study;
  • Able to give written informed consent;
  • Female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (HRT).

Exclusion Criteria:

  • Diabetic;
  • History of cardiovascular disease, i.e. myocardial infarction or stroke;
  • History of cancer;
  • Taking glucose lowering medication;
  • Taking weight loss medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467220
Other Study ID Numbers  ICMJE H3049-30095-01
NIH-PPG ( Other Grant/Funding Number: National Institutes of Health )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of California, San Francisco
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Marc Hellerstein, MD, PhD University of California, Berkeley; University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP