Obesity Clinical Trial
— TREATOfficial 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.
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 |
Verified date | February 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | University of Wisconsin, Madison |
United States,
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 |
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 |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |