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Time Restricted Feeding for Weight Loss and Cardio-protection

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ClinicalTrials.gov Identifier: NCT02948517
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Krista Varady, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE October 28, 2016
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Body weight [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Plasma lipids [ Time Frame: 12 weeks ]
  • Blood pressure [ Time Frame: 12 weeks ]
  • Insulin resistance measured by Homeostatic model assessment (HOMA) [ Time Frame: 12 weeks ]
  • Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • Plasma lipids [ Time Frame: 12 weeks ]
  • Blood pressure [ Time Frame: 12 weeks ]
  • Insulin resistance measured by Homeostatic model assessment (HOMA) [ Time Frame: 12 weeks ]
  • Inflammatory markers [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time Restricted Feeding for Weight Loss and Cardio-protection
Official Title  ICMJE Time Restricted Feeding for Weight Loss and Cardio-protection
Brief Summary Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is effective for weight loss and cardio-protection in obese adults. It is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.
Detailed Description Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. Recent findings from short-term uncontrolled trials suggest that TRF is effective for weight loss and cardio-protection in obese adults. In view of these pilot findings, it is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers. To test the study objectives, a 14-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline; and (2) 12-week weight loss, will be implemented. Obese subjects (n = 40) will be randomized to 1 of 2 groups: (1) TRF (n = 20), or (2) control (n = 20). This study will be the first randomized controlled trial of TRF, and will show that TRF can be implemented to help obese individuals lose weight and lower risk of coronary heart disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronary Disease
  • Weight Loss
Intervention  ICMJE Other: Time restricted feeding
Time restricted feeding
Study Arms  ICMJE
  • Experimental: Time restricted feeding
    Time restricted feeding
    Intervention: Other: Time restricted feeding
  • No Intervention: Control
    No intervention
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: November 4, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
40
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • Body mass index (BMI) between 30.0 and 40 kg/m2
  • Age between 25 and 65 years
  • Sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week)
  • Weight stable for >3 months prior to the beginning of the study (gain or loss <4 kg)
  • Able to give written informed consent

Exclusion Criteria:

  • Smoker
  • Diabetic
  • History of cardiovascular disease (myocardial infarction or stroke)
  • Taking weight loss medications
  • History of eating disorders
  • Night-shift workers
  • Perimenopausal
  • Pregnant or trying to become pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 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 NCT02948517
Other Study ID Numbers  ICMJE 20160119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Krista Varady, University of Illinois at Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Krista Varady, PhD University of Illinois, Chicago
PRS Account University of Illinois at Chicago
Verification Date April 2018

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