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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00467220
First received: April 26, 2007
Last updated: May 21, 2013
Last verified: May 2013
  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
Moderately Overweight Individuals
Behavioral: calorie restriction

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

Primary Outcome Measures:
  • Adipose tissue dynamics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Calorie Restriction
Subjects in this arm will be asked to follow a calorie-restricted meal plan, daily, for three months.
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.

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467220

Locations
United States, California
San Francisco General Hospital
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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00467220     History of Changes
Other Study ID Numbers: H3049-30095-01, NIH-PPG
Study First Received: April 26, 2007
Last Updated: May 21, 2013
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
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014