Time Restricted Feeding for Weight Loss and Cardio-protection

Coronary Disease Clinical Trial

Official title:

Time Restricted Feeding for Weight Loss and Cardio-protection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948517
• Other study ID #: 20160119
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: April 2018
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Coronary Artery Disease
• Coronary Disease
• Weight Loss

Intervention

Other:
• Time restricted feeding
Time restricted feeding

Locations

Country	Name	City	State
United States	University of Illinois, Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		12 weeks
Secondary	Plasma lipids		12 weeks
Secondary	Blood pressure		12 weeks
Secondary	Insulin resistance measured by Homeostatic model assessment (HOMA)		12 weeks
Secondary	Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)		12 weeks