Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection

July 8, 2020 updated by: Krista Varady, University of Illinois at Chicago
The proposed research will demonstrate that alternate day modified fasting (ADMF) is a suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance, and heart disease prevention. Since many overweight and obese individuals find it difficult to adhere to daily CR, this diet option may improve adherence with these dietary restriction protocols. This, in turn, will allow a greater percent of the overweight and obese population to lose weight, maintain weight loss, and prevent future occurrences of coronary heart disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overweight and obese individuals are at increased risk for coronary heart disease (CHD). Losing weight by means of dietary restriction greatly reduces vascular disease risk. The majority of studies examiningmost common dietary restriction protocol s implemented is daily calorie restriction (CR). Another dietary restriction regimen employed, although far less commonly, is alternate day modified fasting (ADMF). ADMF involves a "feed day" where food is consumed ad-libitum, alternated with a "fast day", where food intake is partially reduced. Previous reports show that adherence to ADMF exceeds that of CR after 8 weeks of treatment. This increased adherence to ADMF results in greater weight loss, which produces more pronounced improvements in CHD risk. What has yet to be determined is whether adherence to ADMF remains near maximal for longer treatment durations (24 weeks), and if this improved adherence results in greater reductions in body weight and CHD risk, versus CR. Once weight loss is achieved, weight maintenance is extremely important as CHD risk can increase if weight is regained. Whether ADMF is an effective strategy for weight maintenance remains unknown. Accordingly, the aims of this proposal are: Aim 1: To establish that adherence to ADMF is greater than that of CR during a 24-week intervention period and to determine if increased adherence to ADMF results in greater weight loss; Aim 2: To establish that greater reductions in body weight by ADMF over a 24-week period will result in greater improvements in traditional CHD risk parameters (blood pressure, plasma lipid levels, cholesterol synthesis rate, LDL particle size, and CRP) and emerging CHD risk parameters (fat cell-derived hormones, body fat distribution, and fat cell size) in comparison to CR; and Aim 3: To establish that ADMF is an effective diet therapy to maintain weight loss and sustain improvements in CHD risk indicators, and to compare changes in cognitive and behavioral components of eating between ADMF and CR subjects. A 52-week randomized, controlled, parallel-arm feeding trial will be implemented to test these objectives. The trial will be divided into 3 consecutive intervention periods: (1) 4-week baseline; (2) 24-week weight loss with food provided; and (3) 24-week weight maintenance with no food provided. Overweight and obese subjects (n = 90) will be randomized to 1 of 3 groups: (1) ADMF, 75% energy restriction on the "fast day" and ad libitum fed on the "feed day"; (2) CR, 25% restriction everyday; or 3) control, 100% energy intake everyday. During the weight maintenance phase, ADMF subjects will consume 25% of their energy needs on the "fast day" and 175% of their needs on the "feed day", while CR and control subjects will consume 100% of their needs everyday. Our findings will show that ADMF can be implemented as an alternative to CR to help overweight and obese individuals lose weight, maintain weight loss, and sustain reductions in CHD risk. This study will also generate insights into the specific behavioral changes that occur with ADMF that explain why ADMF is a successful diet strategy for weight maintenance.

Study Type

Interventional

Enrollment (Actual)

100

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
    • Illinois
      • Chicago, Illinois, United States, 60622
        • University of Illinois, Chicago

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria. Adult subjects meeting the following criteria will be eligible to participate:

  • Age between 18 to 65 years old
  • BMI between 25.0 and 39.9 kg/m2
  • Previously sedentary (<60 minutes/week of light activity corresponding to 2.5 to 4.0 metabolic equivalents (METs) for the 3 months prior to the study)

Exclusion criteria. Subjects excluded from participating in the study include those who:

  • Have a history cardiovascular disease (prior angina, myocardial infarction or stroke)
  • Are diabetic (fasting blood glucose > 126 mg/dl)
  • Have a history of psychiatric disorders and/or eating disorders
  • Are taking anti-depressant or anti-anxiety medications
  • Are taking drugs that affect study outcomes (weight loss, lipid-lowering, or blood pressure drugs)
  • Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
  • Are not able to keep a food diary or activity log for 7 consecutive days during screening
  • Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
  • Are claustrophobic or have implanted electrical devices (cardiac pacemaker or a neurostimulator)
  • Are pregnant, or trying to become pregnant
  • Are smokers

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
Experimental: Alternate day fasting (ADF)
Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)
Other: Alternate day fasting
Experimental: Calorie restriction (CR)
75% energy intake every day
Other: Calorie restriction
Active Comparator: Control
Usual diet
Other: Control diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline to month 12
Change in body weight from baseline to month 12
Baseline to month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HDL Cholesterol
Time Frame: 12 month interval
Change in HDL cholesterol from baseline to month 12
12 month interval
Change in Systolic Blood Pressure
Time Frame: 12 month interval
Change in systolic blood pressure from baseline to month 12
12 month interval
Change in Fasting Glucose
Time Frame: 12 month interval
Change in fasting glucose from baseline to month 12
12 month interval
Change in Fasting Insulin
Time Frame: 12 month interval
Change in fasting insulin from baseline to month 12
12 month interval
Change in Insulin Resistance Measured by HOMA-IR
Time Frame: 12 month interval
Change in insulin resistance measured by HOMA-IR from baseline to month 12
12 month interval
Change in Plasma C-reactive Protein Concentrations
Time Frame: 12 month interval
Change in plasma C-reactive protein concentrations from baseline to month 12
12 month interval
Change in Plasma Homocysteine Concentrations
Time Frame: 12 month interval
Change in plasma Homocysteine concentrations from baseline to month 12
12 month interval

Collaborators and Investigators

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

Sponsor

University of Illinois at Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Krista Varady, PhD, University of Illinois, Chicago

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

September 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0118
  • R01HL106228 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Obesity

Clinical Trials on Alternate day fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe