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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - 65
Updated:4/21/2016
Start Date:April 2007
End Date:April 2018

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

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.

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
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