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

January 17, 2020 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Subjects will follow all study tasks but will not be required to follow a calorie-restricted meal plan.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipose tissue dynamics
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Marc Hellerstein, MD, PhD, University of California, Berkeley; University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 17, 2015

Study Completion (Actual)

December 17, 2015

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

April 30, 2007

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H3049-30095-01
  • NIH-PPG (Other Grant/Funding Number: National Institutes of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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