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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating plan | Experimental | 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. |
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| Consistent Meal Timing Plan | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted Eating plan | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Measure changes in weight during the 12 week study | Daily for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in lean mass | Measure changes in lean mass during the 12 week study using DXA data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan J Weiss, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36796647 | Derived | 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. | |
| 32986097 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2019 | Feb 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D015431 | Weight Loss |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study.
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| Consistent Meal timing plan | 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. |
|
| Measured twice: Once at study start and once 12 weeks later |
| Fasting insulin levels | Measure fasting insulin levels pre and post intervention | Measured twice: Once at study start and once 12 weeks later |
| Resting metabolic rate | Will measure participants resting metabolic rate | Measured twice: Once at study start and once 12 weeks later |
| 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 |
| 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 |
| 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 |
| Derived |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |