Insulin Resistance, Obesity
Conditions
Keywords
Weight loss, Diet, Time-restricted feeding
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).
Interventions
BEHAVIORALTime-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.
BEHAVIORALConsistent 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.
Sponsors
University of Wisconsin, Madison
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | Daily for 12 weeks | Measure changes in weight during the 12 week study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lean mass | Measured twice: Once at study start and once 12 weeks later | Measure changes in lean mass during the 12 week study using DXA data |
| Fasting insulin levels | Measured twice: Once at study start and once 12 weeks later | Measure fasting insulin levels pre and post intervention |
| Resting metabolic rate | Measured twice: Once at study start and once 12 weeks later | Will measure participants resting metabolic rate |
| Fat loss | Measured twice: Once at study start and once 12 weeks later | Measure changes in fat mass during the 12 week study using DXA data |
| Changes in fasting glucose levels | Measured twice: Once at study start and once 12 weeks later | WIll measure fasting blood glucose levels prior to diet intervention and again at study completion |
| Changes in HbA1c levels | Measured twice: Once at study start and once 12 weeks later | WIll measure HbA1c levels prior to diet intervention and again at study completion |
| Total energy expenditure | Measured twice: Once at study start and once 12 weeks later | Will measure participants total energy expenditure during the week leading up to the study start and during the final week of the study |
Countries
United States
Outcome results
None listed