Time Restricted Feeding for Weight Loss and Cardio-protection

Not Applicable

Completed

• Conditions: Weight Loss; Coronary Disease
• Interventions: Other: Time restricted feeding

• Registration Number: NCT02948517
• Lead Sponsor: University of Illinois at Chicago

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time restricted feeding	Time restricted feeding	Time restricted feeding

Primary Outcome Measures

Name	Time	Method
Body weight	12 weeks

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)	12 weeks
Plasma lipids	12 weeks
Blood pressure	12 weeks
Insulin resistance measured by Homeostatic model assessment (HOMA)	12 weeks

Trial Locations

Locations (1)

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States