Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study systematically quantified the effects of intermittent fasting and caloric
      restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat
      mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate
      utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were
      enrolled in the study as a single cohort and participated in an 12-week trial consisting of
      two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2)
      11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to
      maintain their body weight by consuming their normal food intake; however, during the 11 week
      IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of
      body weight loss per week. At the conclusion of the 12 week weight loss study, all 40
      participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they
      agreed to participate, groups were balanced so there were similar numbers of men and women
      and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a
      modified version of the 12 week weight loss intervention that consumes whole foods along with
      2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the
      Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n=
      18) and asked to follow these nutritional guidelines ad libitum for the duration of 12
      months.
    

Detailed description: 
      Participants were non-smoking, healthy, but overweight/obese men and women with no known
      cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive
      medical examination by their physicians. All participants were sedentary or lightly active
      (<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity
      questionnaire, overweight or obese (BMI>27.5 kg/m2; % body fat>30%), middle aged (30-65
      years), and weight stable (+/-2kg) for at least 6 months prior to beginning the study.
      Individuals with a history of cardiometabolic disease (e.g. diabetes, heart disease, etc)
      and/or cancer and presently taking medications for these conditions, who are pregnant or may
      be pregnant, are allergic to milk products or are anorexic or bulimic were excluded from
      participation. Each participant provided informed written consent in adherence with the
      Skidmore College Human Subjects review board prior to participation and the study was
      approved by the Human Subjects Institutional Review Board of Skidmore College. All
      experimental procedures were performed in accordance with the Federal Wide Assurance and
      related New York State regulations, which are consistent with the National Commission for the
      Protection of Human Subjects of Biomedical and Behavioral Research and in agreement with the
      Helsinki Declaration as revised in 1983.
    

Intervention name(s): Weight Loss Phase; HP-IF; HH
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): High Protein, Intermittent Fast, Low Calorie Diet; High Protein, Intermittent Fast; Heart Healthy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment