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Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women

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ClinicalTrials.gov Identifier: NCT02525419
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
Isagenix International LLC
Information provided by (Responsible Party):
Skidmore College

Tracking Information
First Submitted Date  ICMJE August 12, 2015
First Posted Date  ICMJE August 17, 2015
Last Update Posted Date August 24, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
Change in Total Body Fat, kg [ Time Frame: Baseline, 12 week, 64 weeks ]
Quantitative measure of total body fat using the iDXA (dual x-ray absorptiometry)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
  • Change in Serum Toxins [ Time Frame: Baseline, 12 weeks, 64 weeks ]
    Blood Draw
  • Change in Resting Energy Metabolism [ Time Frame: Baseline, 12 weeks, 64 weeks ]
    indirect Calorimetry
  • Change in Body Weight, kg [ Time Frame: Baseline, 12 week, 64 weeks ]
    Total body weight measurement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
Official Title  ICMJE Effects of Intermittent Fasting and Caloric Restriction on Total and Regional Body Composition, Cardiometabolic, Oxidative Stress & Plasma Toxin Biomarkers, and Energy Metabolism in Overweight/Obese Men and Women
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • Behavioral: Weight Loss Phase
    High Protein, Intermittent Fast, Low Calorie Diet
  • Behavioral: HP-IF
    High Protein, Intermittent Fast
  • Behavioral: HH
    Heart Healthy
Study Arms  ICMJE
  • Experimental: Weight Loss Phase
    12 week weight loss phase consisting of High Protein - Intermittent Fast-Low Calorie diet in 43 Obese Men and Women
    Intervention: Behavioral: Weight Loss Phase
  • Experimental: Weight Loss Maintenance Phase
    52 week weight loss maintenance phase consisting of either High Protein - Intermittent Fast (HP-IF) or Heart Healthy (HH) diet
    Interventions:
    • Behavioral: HP-IF
    • Behavioral: HH
Publications * Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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%)
  • Weight stable (+/-2kg) for at least 6 months prior to beginning the study

Exclusion Criteria:

  • History of cardiometabolic disease (e.g. diabetes, heart disease, etc) and/or cancer and presently taking medications for these conditions
  • Pregnant or may be pregnant, are allergic to milk products or are anorexic or bulimic
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02525419
Other Study ID Numbers  ICMJE 1307-347
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Skidmore College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Skidmore College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Isagenix International LLC
Investigators  ICMJE
Principal Investigator: Paul Arciero, Doctorate Faculty
PRS Account Skidmore College
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP