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

Primary Purpose

Moderately Overweight Individuals

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
calorie restriction
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Moderately Overweight Individuals focused on measuring Calorie restriction, alternate day fasting, calorie intake

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Control

Alternate Day Fasting Arm

Calorie Restriction

Arm Description

Subjects will follow all study tasks but will not be required to follow a calorie-restricted meal plan.

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.

Subjects in this arm will be asked to follow a calorie-restricted meal plan, daily, for three months.

Outcomes

Primary Outcome Measures

Adipose tissue dynamics
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.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2007
Last Updated
January 17, 2020
Sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00467220
Brief Title
Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer
Acronym
1072
Official Title
Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 17, 2015 (Actual)
Study Completion Date
December 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderately Overweight Individuals
Keywords
Calorie restriction, alternate day fasting, calorie intake

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will follow all study tasks but will not be required to follow a calorie-restricted meal plan.
Arm Title
Alternate Day Fasting Arm
Arm Type
Other
Arm Description
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.
Arm Title
Calorie Restriction
Arm Type
Other
Arm Description
Subjects in this arm will be asked to follow a calorie-restricted meal plan, daily, for three months.
Intervention Type
Behavioral
Intervention Name(s)
calorie restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adipose tissue dynamics
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Hellerstein, MD, PhD
Organizational Affiliation
University of California, Berkeley; University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived

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

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