Study of Time-restricted Eating on Weight Loss.

Obesity Clinical Trial

— TREAT  

Official title:

Study of Time-restricted Eating on Weight Loss. A Randomized Controlled Trial of the Effects of Time-restricted Eating on Weight Loss in Obese Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393195
• Other study ID #: 17-22110
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial studying the effects of time-restricted eating (TRE) on weight loss in obese humans. Obesity is the number one risk factor for type 2 Diabetes Mellitus (T2DM), and numerous studies demonstrate that weight loss is an effective strategy to prevent T2DM and improve the metabolic health of people diagnosed with T2DM. Unfortunately, classical calorie restriction diets often fail to produce long-term weight loss due to low compliance, reduced resting metabolic rate (RMR), and other factors. Therefore, novel dieting techniques must be explored in order to successfully treat obesity and prevent T2DM. Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and metabolic health markers in the absence of calorie restriction. Limited research in human subjects suggests that this feeding paradigm may translate to human health as well, however, more research needs to be done in order to confirm this hypothesis. This study will determine if TRE can lead to weight loss in obese human subjects. Secondary outcomes include changes in body composition, HOMA-IR, hormonal and biochemical serum markers, RMR, and total energy expenditure (TEE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 10, 2020
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• BMI between 30-40 kg/m2

• Participants must regularly consume breakfast (at least 5 days per week)

• Must speak, read, and comprehend English

• Access to reliable internet and/or wifi

• Must have a valid email address and phone number

• Must have a cellular phone with data plan

Exclusion Criteria:

• HIV or immunocompromised

• Current or past cancer diagnosis

• Pregnant, breastfeeding, or planned pregnancy in next 6 months

• Beginning or ending hormonal contraception in next 6 months

• Current diagnosis of type or type 2 diabetes

• Currently taking glucose-lowering drugs, statins, or oral steroids

• History of gastric bypass surgery or any other weight-loss surgery

• History of anorexia or bulimia

• Frequent travel across time zones or unusual work hours

• Unable to fast for prolonged periods due to medical condition

• Unable to stand for several minutes without aid

• Cannot lie down on cushioned table for 30 minutes

• No internal metal artifacts that would alter body composition

• Unable to travel to UCSF for in-person testing

• Requires translator services

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Weight Loss

Intervention

Behavioral:
• Time-restricted Eating plan
Research team will prescribe an eating plan for the participant to follow for the 12 week study. The eating plan will consist of eating during a specified 8 hour window and fasting for the remaining 16 hours of the day.
• Consistent Meal timing plan
Research team will prescribe an eating plan for the participant to follow for the 12 week study.The eating plan will consist of eating three structured meals each day during three specified meal windows.

Locations

Country	Name	City	State
United States	UCSF Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Measure changes in weight during the 12 week study	Daily for 12 weeks
Secondary	Fat loss	Measure changes in fat mass during the 12 week study using DXA data	Measured twice: Once at study start and once 12 weeks later
Secondary	Changes in lean mass	Measure changes in lean mass during the 12 week study using DXA data	Measured twice: Once at study start and once 12 weeks later
Secondary	Fasting insulin levels	Measure fasting insulin levels pre and post intervention	Measured twice: Once at study start and once 12 weeks later
Secondary	Resting metabolic rate	Will measure participants resting metabolic rate	Measured twice: Once at study start and once 12 weeks later
Secondary	Total energy expenditure	Will measure participants total energy expenditure during the week leading up to the study start and during the final week of the study	Measured twice: Once at study start and once 12 weeks later
Secondary	Changes in fasting glucose levels	WIll measure fasting blood glucose levels prior to diet intervention and again at study completion	Measured twice: Once at study start and once 12 weeks later
Secondary	Changes in HbA1c levels	WIll measure HbA1c levels prior to diet intervention and again at study completion	Measured twice: Once at study start and once 12 weeks later