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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease Obesity Weight Loss | Other: Alternate day fasting Other: Calorie restriction Other: Control diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Alternate day fasting (ADF)
Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)
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Other: Alternate day fasting |
Experimental: Calorie restriction (CR)
75% energy intake every day
|
Other: Calorie restriction |
Active Comparator: Control
Usual diet
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Other: Control diet |
- Body Weight [ Time Frame: Baseline to month 12 ]Change in body weight from baseline to month 12
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960505
United States, Illinois | |
University of Illinois, Chicago | |
Chicago, Illinois, United States, 60622 |
Principal Investigator: | Krista Varady, PhD | University of Illinois, Chicago |
Responsible Party: | Krista Varady, Associate Professor, University of Illinois at Chicago |
ClinicalTrials.gov Identifier: | NCT00960505 |
Other Study ID Numbers: |
2010-0118 R01HL106228 ( U.S. NIH Grant/Contract ) |
First Posted: | August 17, 2009 Key Record Dates |
Results First Posted: | July 9, 2020 |
Last Update Posted: | July 21, 2020 |
Last Verified: | July 2020 |
Diet Coronary heart disease Obesity Weight loss Weight maintenance |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Body Weight Weight Loss |
Cardiovascular Diseases Body Weight Changes Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |