Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03393195
Other study ID # 17-22110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2