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Sponsors and Collaborators: |
University of California, San Francisco National Institutes of Health (NIH) |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00467220 |
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 |
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Calorie Restriction Alternate Day Fasting |
Behavioral: calorie restriction |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
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.
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Drina Boban, MPH | 415-476-3670 ext 1 |
United States, California | |
San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94110 |
Principal Investigator: | Marc Hellerstein, MD, PhD | University of California, Berkeley; University of California, San Francisco |
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 |
Calorie restriction alternate day fasting calorie intake |
Cardiovascular Diseases |