ObesityTREATNCT03393195
Study of Time-restricted Eating on Weight Loss.
A study testing Time-restricted Eating plan and Consistent Meal timing plan in people with Obesity and Insulin Resistance, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Time-restricted Eating plan and Consistent Meal timing plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94143
About this study
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.
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).
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Time-restricted Eating plan, Consistent Meal timing plan
- Keywords
- Weight loss, Diet, Time-restricted feeding
- Medical subject headings
- Obesity, Insulin Resistance, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted Eating planBehavioural
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 planBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Time-restricted Eating plan |
| 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. Receives: Behavioral: Consistent Meal timing plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measure changes in weight during the 12 week study
Measured: Daily for 12 weeks
Secondary outcomes (7)
Fat loss
Measure changes in fat mass during the 12 week study using DXA data
Measured: 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
Measured: Measured twice: Once at study start and once 12 weeks later
Fasting insulin levels
Measure fasting insulin levels pre and post intervention
Measured: Measured twice: Once at study start and once 12 weeks later
Resting metabolic rate
Will measure participants resting metabolic rate
Measured: 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: 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: 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: Measured twice: Once at study start and once 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start30 Jul 2018
- Primary completion23 Oct 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Ethan J Weiss, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393195
- Sponsor's protocol ID
- 17-22110
- Acronym
- TREAT
- Status last verified
- Feb 2020
- First submitted
- 20 Dec 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36796647Lowe 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.
PubMed 32986097
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03393195
- Acronym / sponsor ID
- TREAT / 17-22110
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Weight loss, Diet, Time-restricted feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating plan | Experimental | Behavioral: Time-restricted Eating planParticipants 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. |
| Consistent Meal Timing Plan | Active comparator | Behavioral: Consistent Meal timing planParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted Eating planResearch 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. | Behavioural | Time-restricted eating plan |
| Consistent Meal timing planResearch 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. | Behavioural | Consistent Meal Timing Plan |
Primary outcome
Weight Loss
Time frame: Daily for 12 weeks
Measure changes in weight during the 12 week study
7 secondary outcomes
Fat loss
Time frame: Measured twice: Once at study start and once 12 weeks later
Changes in lean mass
Time frame: Measured twice: Once at study start and once 12 weeks later
Fasting insulin levels
Time frame: Measured twice: Once at study start and once 12 weeks later
Resting metabolic rate
Time frame: Measured twice: Once at study start and once 12 weeks later
Total energy expenditure
Time frame: Measured twice: Once at study start and once 12 weeks later
Changes in fasting glucose levels
Time frame: Measured twice: Once at study start and once 12 weeks later
Changes in HbA1c levels
Time frame: Measured twice: Once at study start and once 12 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 36796647Wong 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.
- Derived from this study: PubMed 32986097Lowe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan J Weiss, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted Eating plan and Consistent Meal timing plan in people with Obesity and Insulin Resistance, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: Daily for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393195, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.