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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Disease Weight Loss Other: Time restricted feeding Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Time Restricted Feeding for Weight Loss and Cardio-protection
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Time restricted feeding
Time restricted feeding
 Other: Time restricted feeding
Time restricted feeding
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Body weight [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Plasma lipids [ Time Frame: 12 weeks ]
  2. Blood pressure [ Time Frame: 12 weeks ]
  3. Insulin resistance measured by Homeostatic model assessment (HOMA) [ Time Frame: 12 weeks ]
  4. Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6) [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT02948517


Locations
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United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60622
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Krista Varady, PhD University of Illinois, Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Krista Varady, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02948517    
Other Study ID Numbers: 20160119
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Disease
Body Weight
Weight Loss
Body Weight Changes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases