Study of Time-restricted Eating on Weight Loss.

Completed · Not applicable

Conditions studied: Obesity, Insulin Resistance

In brief

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).

Key facts

Study ID

NCT03393195

Run by

University of California, San Francisco

People needed

137

Starts

2018-07-30

Expected to finish

2020-01-10

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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