N/A
N=100
Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Coronary Heart Disease · Obesity · Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT00960505 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Body Weight — -4.6; -4.5; 0.3 Percent change at month 12
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alternate day fasting (Other); Calorie restriction (Other); Control diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight |
-4.6; -4.5; 0.3 | — |
| SECONDARY Change in HDL Cholesterol |
4.6; -0.5; -3.4 | — |
| SECONDARY Change in Systolic Blood Pressure |
-3.5; -2.9; -2.6 | — |
| SECONDARY Change in Fasting Glucose |
4.0; -1.9; 10.7 | — |
| SECONDARY Change in Fasting Insulin |
-35; -28; -2.5 | — |
| SECONDARY Change in Insulin Resistance Measured by HOMA-IR |
-36; -34; 12 | — |
| SECONDARY Change in Plasma C-reactive Protein Concentrations |
-13.9; -6.2; 5.4 | — |
| SECONDARY Change in Plasma Homocysteine Concentrations |
0.2; -1.2; -2.6 | — |
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.
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00960505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.