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Effect of Daily Calorie or Alternate-Day Calorie Reductions on Risk for Cardiovascular Disease and Cancer
This study is currently recruiting participants.
Verified by University of California, San Francisco, April 2007
Sponsors and Collaborators: University of California, San Francisco
National Institutes of Health (NIH)
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00467220
  Purpose

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.


Condition Intervention
Calorie Restriction
Alternate Day Fasting
Behavioral: calorie restriction

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect of Daily Calorie Restriction or Alternate-Day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 40
Study Start Date: April 2007
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-libitum 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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male; body mass index (BMI) between 22-26.9 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.

Exclusion Criteria:

  • Diabetic;
  • History of cardiovascular disease, i.e. myocardial infarction or stroke;
  • History of cancer;
  • Taking glucose lowering medication;
  • Taking weight loss medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467220

Contacts
Contact: Drina Boban, MPH 415-476-3670 ext 1

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Marc Hellerstein, MD, PhD University of California, Berkeley; University of California, San Francisco
  More Information

Study ID Numbers: H3049-30095-01
Study First Received: April 26, 2007
Last Updated: April 27, 2007
ClinicalTrials.gov Identifier: NCT00467220  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Calorie restriction
alternate day fasting
calorie intake

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009