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CompletedNCT02948517Updated May 2, 2018

Time Restricted Feeding for Weight Loss and Cardio-protection

An interventional study of Time restricted feeding in Coronary Disease and Weight Loss, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Disease
  • Weight Loss
03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's enrollment of 31 is below the median of 124 across 1,583 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Time restricted feeding

    Time restricted feeding

    Other: Time restricted feeding

  • No intervention
    Control

    No intervention

Interventions

  • OtherTime restricted feeding

    Time restricted feeding

06

What researchers measure

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • University of Illinois, Chicago
    Chicago, Illinois 60622, United States
08

References and documents

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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. PubMed 33512717 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02948517
Lead sponsor
University of Illinois at Chicago
Responsible party
Krista Varady (Associate Professor, University of Illinois at Chicago) — Principal investigator
First posted
Oct 28, 2016
Start date
Sep 2016
Primary completion
Aug 2017
Completion
Aug 2017
Last update
May 2, 2018

Study contacts

Krista Varady, PhD
principal investigator · University of Illinois Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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