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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Weight Loss Phase Behavioral: HP-IF Behavioral: HH Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Weight Loss Phase
12 week weight loss phase consisting of High Protein - Intermittent Fast-Low Calorie diet in 43 Obese Men and Women
 Behavioral: Weight Loss Phase
High Protein, Intermittent Fast, Low Calorie Diet
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
 Behavioral: HP-IF
High Protein, Intermittent Fast

Behavioral: HH
Heart Healthy


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in Serum Toxins [ Time Frame: Baseline, 12 weeks, 64 weeks ]
    Blood Draw

  2. Change in Resting Energy Metabolism [ Time Frame: Baseline, 12 weeks, 64 weeks ]
    indirect Calorimetry

  3. Change in Body Weight, kg [ Time Frame: Baseline, 12 week, 64 weeks ]
    Total body weight measurement


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525419


Locations
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United States, New York
Human Nutrition and Metabolism Laboratory
Saratoga Springs, New York, United States, 12866
Sponsors and Collaborators
Skidmore College
Isagenix International LLC
Investigators
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Principal Investigator: Paul Arciero, Doctorate Faculty
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Skidmore College
ClinicalTrials.gov Identifier: NCT02525419    
Other Study ID Numbers: 1307-347
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight