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Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer

35 Years
65 Years
Open (Enrolling)
Moderately Overweight Individuals

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Trial Information

Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Adipose tissue dynamics

Outcome Description:

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.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Marc Hellerstein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Berkeley; University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

April 2015

Related Keywords:

  • Moderately Overweight Individuals
  • Calorie restriction
  • alternate day fasting
  • calorie intake
  • Cardiovascular Diseases
  • Overweight



San Francisco General Hospital San Francisco, California  94110