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Time Restricted Feeding for Weight Loss and Cardio-protection

Primary Purpose

Coronary Disease, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted feeding
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois, Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Time restricted feeding

Control

Arm Description

Time restricted feeding

No intervention

Outcomes

Primary Outcome Measures

Body weight

Secondary Outcome Measures

Plasma lipids
Blood pressure
Insulin resistance measured by Homeostatic model assessment (HOMA)
Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)

Full Information

First Posted
October 25, 2016
Last Updated
April 30, 2018
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02948517
Brief Title
Time Restricted Feeding for Weight Loss and Cardio-protection
Official Title
Time Restricted Feeding for Weight Loss and Cardio-protection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time restricted feeding
Arm Type
Experimental
Arm Description
Time restricted feeding
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Time restricted feeding
Intervention Description
Time restricted feeding
Primary Outcome Measure Information:
Title
Body weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Plasma lipids
Time Frame
12 weeks
Title
Blood pressure
Time Frame
12 weeks
Title
Insulin resistance measured by Homeostatic model assessment (HOMA)
Time Frame
12 weeks
Title
Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Varady, PhD
Organizational Affiliation
University of Illinois, Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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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Time Restricted Feeding for Weight Loss and Cardio-protection

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