Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Condition: Coronary Heart Disease; Obesity; Weight Loss
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Body Weight; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Alternate day fasting; Calorie restriction; Control diet
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet; Coronary heart disease; Obesity; Weight loss; Weight maintenance