Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Phase
HP-IF
HH
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility 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
Sites / Locations
- Human Nutrition and Metabolism Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Weight Loss Phase
Weight Loss Maintenance Phase
Arm Description
12 week weight loss phase consisting of High Protein - Intermittent Fast-Low Calorie diet in 43 Obese Men and Women
52 week weight loss maintenance phase consisting of either High Protein - Intermittent Fast (HP-IF) or Heart Healthy (HH) diet
Outcomes
Primary Outcome Measures
Change in Total Body Fat, kg
Quantitative measure of total body fat using the iDXA (dual x-ray absorptiometry)
Secondary Outcome Measures
Change in Serum Toxins
Blood Draw
Change in Resting Energy Metabolism
indirect Calorimetry
Change in Body Weight, kg
Total body weight measurement
Full Information
NCT ID
NCT02525419
First Posted
August 12, 2015
Last Updated
August 21, 2015
Sponsor
Skidmore College
Collaborators
Isagenix International LLC
1. Study Identification
Unique Protocol Identification Number
NCT02525419
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skidmore College
Collaborators
Isagenix International LLC
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight Loss Phase
Arm Type
Experimental
Arm Description
12 week weight loss phase consisting of High Protein - Intermittent Fast-Low Calorie diet in 43 Obese Men and Women
Arm Title
Weight Loss Maintenance Phase
Arm Type
Experimental
Arm Description
52 week weight loss maintenance phase consisting of either High Protein - Intermittent Fast (HP-IF) or Heart Healthy (HH) diet
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Phase
Intervention Description
High Protein, Intermittent Fast, Low Calorie Diet
Intervention Type
Behavioral
Intervention Name(s)
HP-IF
Intervention Description
High Protein, Intermittent Fast
Intervention Type
Behavioral
Intervention Name(s)
HH
Intervention Description
Heart Healthy
Primary Outcome Measure Information:
Title
Change in Total Body Fat, kg
Description
Quantitative measure of total body fat using the iDXA (dual x-ray absorptiometry)
Time Frame
Baseline, 12 week, 64 weeks
Secondary Outcome Measure Information:
Title
Change in Serum Toxins
Description
Blood Draw
Time Frame
Baseline, 12 weeks, 64 weeks
Title
Change in Resting Energy Metabolism
Description
indirect Calorimetry
Time Frame
Baseline, 12 weeks, 64 weeks
Title
Change in Body Weight, kg
Description
Total body weight measurement
Time Frame
Baseline, 12 week, 64 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Arciero, Doctorate
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition and Metabolism Laboratory
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33512717
Citation
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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived
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Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
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