Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults

Obesity Clinical Trial

Official title:

Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867773
• Other study ID #: 2018-1525
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: June 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.

Description:

Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female;
• body mass index (BMI) between 30.0 and 49.9 kg/m2;
• age between 18 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;
• taking weight loss medications;
• taking medication that requires eating food before (or with) the medication; history of eating disorders;
• night-shift workers;
• perimenopausal;
• pregnant women

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Weight Loss

Intervention

Behavioral:
• Time restricted feeding
TRF subjects will consume food ad libitum during the feeding window (4-h or 6-h window), and refrain from eating during the fasting window (20-h or 18-h window)

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	Change from baseline to week 8 in body weight	Measured by an electronic scale	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in body composition	Measured by DXA	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in Insulin resistance	Measured as HOMA-IR	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in Fasting glucose	Measured with a hexokinase reagent kit	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in Fasting insulin	Measured as total immunoreactive insulin	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in Blood pressure	Measured by a blood pressure cuff	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in adverse events	Measured by questionnaire	Measured weekly from baseline to week 8
Secondary	Change from baseline to week 8 in plasma lipids	Measured by outside lab (Medstart, IN)	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in heart rate	Measured by a blood pressure cuff	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)	Measured by ELISA	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in oxidative stress (8-isoprostane)	Measured by ELISA	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in calorie and macronutrient intake	Measured by food record	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in physical activity (steps/d)	Measured by activity monitor	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in diet adherence	Measured by a questionnaire	Measured weekly from baseline to week 8
Secondary	Change from baseline to week 8 in sleep quality	Measured by a questionnaire	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in insomnia severity	Measured by a questionnaire	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in risk of sleep apnea	Measured by a questionnaire	Measured at week 1 and 8
Secondary	Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)	Measured by a ELISA	Measured at week 1 and 8