Study of Time-restricted Eating on Weight Loss.

NCT ID: NCT03393195

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2020-01-10

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).

Conditions

Obesity; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Time-restricted eating plan

Participants in this group will be instructed to fast every day from 8pm until 12pm the following day. From 12pm until 8pm, participants can eat and drink whatever they want. During fasting hours, participants can drink water and black coffee.

Group Type: EXPERIMENTAL

Time-restricted Eating plan

Intervention Type: BEHAVIORAL

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

Participants in this group will be instructed to eat three daily meals during specified eating times. Their first meal will be between 7am-11am. Second meal between 11am and 3pm, and third meal between 4pm-10pm. Participants will be encouraged to eat small snacks if needed so that they can eat their next meal during the specified window.

Group Type: ACTIVE_COMPARATOR

Consistent Meal timing plan

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ethan J Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Medical Center

San Francisco, California, United States

Countries

United States

References

Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.

Reference Type: DERIVED

PMID: 36796647 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32986097 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-22110

Identifier Type: -

Identifier Source: org_study_id