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

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ClinicalTrials.gov Identifier: NCT00960505
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : July 9, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
Pennington Biomedical Research Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Krista Varady, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Results First Submitted Date  ICMJE May 22, 2017
Results First Posted Date  ICMJE July 9, 2020
Last Update Posted Date July 21, 2020
Study Start Date  ICMJE September 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
Body Weight [ Time Frame: Baseline to month 12 ]
Change in body weight from baseline to month 12
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
Body Weight [ Time Frame: Weekly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • Change in HDL Cholesterol [ Time Frame: 12 month interval ]
    Change in HDL cholesterol from baseline to month 12
  • Change in Systolic Blood Pressure [ Time Frame: 12 month interval ]
    Change in systolic blood pressure from baseline to month 12
  • Change in Fasting Glucose [ Time Frame: 12 month interval ]
    Change in fasting glucose from baseline to month 12
  • Change in Fasting Insulin [ Time Frame: 12 month interval ]
    Change in fasting insulin from baseline to month 12
  • 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
  • Change in Plasma C-reactive Protein Concentrations [ Time Frame: 12 month interval ]
    Change in plasma C-reactive protein concentrations from baseline to month 12
  • Change in Plasma Homocysteine Concentrations [ Time Frame: 12 month interval ]
    Change in plasma Homocysteine concentrations from baseline to month 12
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • Adipokine concentrations [ Time Frame: 4-week intervals ]
  • Cholesterol concentrations [ Time Frame: 4-week intervals ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Official Title  ICMJE Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronary Heart Disease
  • Obesity
  • Weight Loss
Intervention  ICMJE
  • Other: Alternate day fasting
  • Other: Calorie restriction
  • Other: Control diet
Study Arms  ICMJE
  • Experimental: Alternate day fasting (ADF)
    Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)
    Intervention: Other: Alternate day fasting
  • Experimental: Calorie restriction (CR)
    75% energy intake every day
    Intervention: Other: Calorie restriction
  • Active Comparator: Control
    Usual diet
    Intervention: Other: Control diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
100
Original Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
20
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960505
Other Study ID Numbers  ICMJE 2010-0118
R01HL106228 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krista Varady, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE
  • Pennington Biomedical Research Center
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Krista Varady, PhD University of Illinois, Chicago
PRS Account University of Illinois at Chicago
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP