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History of Changes for Study: NCT03393195
Study of Time-restricted Eating on Weight Loss. (TREAT)
Latest version (submitted February 28, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 2, 2018 None (earliest Version on record)
2 January 5, 2018 Sponsor/Collaborators and Study Status
3 August 1, 2018 Recruitment Status, Study Status and Contacts/Locations
4 October 10, 2018 Study Status
5 September 5, 2019 Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Study Design
6 November 12, 2019 Study Status and Study Description
7 February 27, 2020 Recruitment Status, Study Status, Study Design and Outcome Measures
8 February 28, 2020 Documents, IPDSharing and Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT03393195
January 2, 2018 (v1) -- February 28, 2020 (v8)

Changes in: Study Status, Sponsor/Collaborators, Contacts/Locations, Study Design, Documents, IPDSharing, Outcome Measures and Study Description

Study Identification
Unique Protocol ID: 17-22110 17-22110
Brief Title: Study of Time-restricted Eating on Weight Loss. (TREAT)Study of Time-restricted Eating on Weight Loss. (TREAT)
Official 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. 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.
Secondary IDs:
Study Status
Record Verification: January 2018 February 2020
Overall Status: Not yet recruiting Completed
Study Start: February 2018 July 30, 2018
Primary Completion: August 2018 [Anticipated ] October 23, 2019 [Actual ]
Study Completion: August 2018 [Anticipated ] January 10, 2020 [Actual ]
First Submitted: December 20, 2017 December 20, 2017
First Submitted that
Met QC Criteria:
January 2, 2018 January 2, 2018
First Posted: January 8, 2018 [Actual ] January 8, 2018 [Actual ]
Last Update Submitted that
Met QC Criteria:
January 2, 2018 February 28, 2020
Last Update Posted: January 8, 2018 [Actual ] March 3, 2020 [Actual ]
Sponsor/Collaborators
Sponsor: University of California, San Francisco University of California, San Francisco
Responsible Party: Principal Investigator
Investigator: Ethan J Weiss
Official Title: Ethan J Weiss M.D.
Affiliation: University of California, San Francisco
Sponsor
Collaborators: University of Wisconsin, Madison University of Wisconsin, Madison
Oversight
U.S. FDA-regulated Drug: No No
U.S. FDA-regulated Device: No No
Data Monitoring: No No
Study Description
Brief Summary: This is a randomized controlled trial studying the effects of time-restricted feeding (TRF) 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). 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).
Detailed Description:
Conditions
Conditions: Obesity
Insulin Resistance
Obesity
Insulin Resistance
Keywords: Weight loss
Diet
Time-restricted feeding
Weight loss
Diet
Time-restricted feeding
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Not ApplicableNot Applicable
Interventional Study Model: Parallel Assignment Parallel Assignment
This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study. This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study.
Number of Arms: 22
Masking: None (Open Label)None (Open Label)
Allocation: RandomizedRandomized
Enrollment: 100 [Anticipated ] 137 [Actual ]
Arms and Interventions
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
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.
Outcome Measures
Primary Outcome Measures:
1. Weight Loss
Measure changes in weight during the 12 week study

[Time Frame: Daily for 12 weeks ]
Weight Loss
Measure changes in weight during the 12 week study

[Time Frame: Daily for 12 weeks ]
Secondary Outcome Measures:
2. Fat loss
Measure changes in fat mass during the 12 week study using DXA data

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
Fat loss
Measure changes in fat mass during the 12 week study using DXA data

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
3. Changes in lean mass
Measure changes in lean mass during the 12 week study using DXA data

[Time Frame: 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

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
4. Waist to hip ratio
Measure changes in WHR during the 12 week study

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
5. Fasting insulin levels
Measure fasting insulin levels pre and post intervention

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
Fasting insulin levels
Measure fasting insulin levels pre and post intervention

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
6. Fasting cholesterol levels
Measure fasting cholesterol levels pre and post intervention

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
7. Fasting adiponectin levels
Measure fasting adiponectin levels pre and post intervention

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
8. Fasting leptin levels
Measure fasting leptin levels pre and post intervention

[Time Frame: Measured pre and post intervention ]
9. Changes in muscle function
Will measure isokinetic and isometric leg strength using biodex machine

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
10. Changes in sleep patterns
Will use the validated Pittsburgh Sleep Quality index to record participatns amount and quality of sleep

[Time Frame: Monthly for three months. Survey will be completed 4 times ]
11. Changes in blood pressure
Will monitor blood pressure daily using the at-home MOCACAE bluetooth blood pressure cuff

[Time Frame: Daily for 12 weeks ]
12. Calorie intake
Will estimate participants energy intake using the ASA24 (from National Cancer Institute)

[Time Frame: Bi-monthly for three months. Survey will be completed 6 times ]
13. Resting metabolic rate
Will measure participants resting metabolic rate

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
Resting metabolic rate
Will measure participants resting metabolic rate

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
14. 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

[Time Frame: 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

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
15. Changes in fasting glucose levels
WIll measure fasting blood glucose levels prior to diet intervention and again at study completion

[Time Frame: 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

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
16. Changes in HbA1c levels
WIll measure HbA1c levels prior to diet intervention and again at study completion

[Time Frame: 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

[Time Frame: Measured twice: Once at study start and once 12 weeks later ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 64 Years 64 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
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

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
Contacts/Locations
Central Contact: Dylan A Lowe, BS
Telephone: 5703509378
Email: Dylan.Lowe@ucsf.edu
Central Contact Backup: Ethan J Weiss, MD
Telephone: 4154763090
Email: ethan.weiss@ucsf.edu
Study Officials: Ethan J Weiss, MD
Principal Investigator
University of California, San Francisco
Locations: United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
IPDSharing
Plan to Share IPD: Undecided No
References
Citations:
Links:
Available IPD/Information:
Documents

Document Date:
Uploaded:
File Name:
Study Protocol and Statistical Analysis Plan
Document Date: May 14, 2019
Uploaded: 02/28/2020 16:56
File Name: Prot_SAP_000.pdf

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