Clinical trial NCT03393195: Study of Time-restricted Eating on Weight Loss.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Weight loss
Diet
Time-restricted feeding
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2018-01-08
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study.
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: Daily for 12 weeks
Secondary outcomes:
measure: Fat loss
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Changes in lean mass
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Fasting insulin levels
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Resting metabolic rate
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Total energy expenditure
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Changes in fasting glucose levels
timeFrame: Measured twice: Once at study start and once 12 weeks later
measure: Changes in HbA1c levels
timeFrame: Measured twice: Once at study start and once 12 weeks later
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ethan J Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, Kelly N, Liu YE, Philip E, Vittinghoff E, Heymsfield SB, Olgin JE, Shepherd JA, Weiss EJ. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1491-1499. doi: 10.1001/jamainternmed.2020.4153.