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

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Coronary Heart Disease
• Interventions: Other: Control diet; Other: Alternate day fasting; Other: Calorie restriction

• Registration Number: NCT00960505
• Lead Sponsor: University of Illinois at Chicago

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 Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Study Start: 2010-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2017-05-22
• Results First Submitted QC: 2020-06-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Results First Posted: 2020-07-09
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control diet	Usual diet
Alternate day fasting (ADF)	Alternate day fasting	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)
Calorie restriction (CR)	Calorie restriction	75% energy intake every day

Primary Outcome Measures

Name	Time	Method
Body Weight	Baseline to month 12	Change in body weight from baseline to month 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States