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History of Changes for Study: NCT02525419
Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
Latest version (submitted August 21, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 13, 2015 None (earliest Version on record)
2 August 21, 2015 Sponsor/Collaborators and Study Status
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Study NCT02525419
Submitted Date:  August 13, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1307-347
Brief Title: Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2015
Overall Status: Completed
Study Start: August 2013
Primary Completion: November 2014 [Actual]
Study Completion: March 2015 [Actual]
First Submitted: August 12, 2015
First Submitted that
Met QC Criteria:
August 13, 2015
First Posted: August 17, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 13, 2015
Last Update Posted: August 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Skidmore College
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Weight Loss
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Factorial Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 43 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Paul Arciero, Doctorate
Principal Investigator
Faculty
Locations: United States, New York
Human Nutrition and Metabolism Laboratory
Saratoga Springs, New York, United States, 12866
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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