ObesityNCT04484987
The Effect of Time-Restricted Eating in Cardiometabolic Health
A study testing 9 hours daily eating window and 15 hours daily eating window in people with Obesity and Pre-diabetes, run by University of California, Davis at 1 site in United States.
Trial summary
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obesity, Pre-diabetes
- What is being tested?
- 9 hours daily eating window and 15 hours daily eating window
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 20 May 2024
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index 30-39.9 kg/m2
- fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
- self-reported habitual eating period > 15 h per day
Who cannot join
- shift worker, recent or expected travel crossing time zones
- fasting >12 h/day more than once a week or vegan
- shift worker, recent or expected travel crossing time zones
- fasting >12 h/day more than once a week or vegan
- > once a week no food intake after 1800 h
- habitually waking up before 0400 h and sleeping before 2230 h
Show all 21Show fewer
- ≥ 150 min per week of structured exercise
- unstable weight (>5% change the last 2 months)
- type 2 diabetes or other major chronic disease
- sleep disorder
- cancer in last 5 years
- conditions that render subject unable to complete all testing procedures
- use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.)
- smoking and illegal drug use
- pregnant or lactating
- menopause
- individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
- gastrointestinal or bariatric surgery
- unable to grant voluntary informed consent or comply with the study instructions
- individuals who are not yet adults (infants, children, teenagers)
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616-5398
About this study
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
- Conditions
- Obesity, Pre-diabetes
- Being tested
- 9 hours daily eating window, 15 hours daily eating window
- Keywords
- Chrono-nutrition, Adipose tissue, Skeletal muscle, Insulin sensitivity, Diurnal rhythm
- Medical subject headings
- Obesity, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9 hours daily eating windowOther
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
15 hours daily eating windowOther
Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TRE group | Other | Time-restricted eating group Receives: Other: 9 hours daily eating window |
| Control group | Other | Time-unrestricted eating group Receives: Other: 15 hours daily eating window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
Measured: 3 months (pre-post intervention)
24 h glycemic control
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Measured: 3 months (pre-post intervention)
Adipose tissue gene expression
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
Measured: 3 months (pre-post intervention)
Secondary outcomes (1)
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
We will evaluate changes in clock gene expression
Measured: 3 months (pre-post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Nov 2020
- Primary completion30 Dec 2022
- Study completion20 May 2024
Why it stopped: Funding withdrawn as the principal investigator moved from the USA to the UK
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484987
- Sponsor's protocol ID
- 1521859
- Status last verified
- Nov 2023
- First submitted
- 17 Jul 2020
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-Restricted Eating in Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT04484987
- Acronym / sponsor ID
- 1521859
- Conditions
- Obesity, Pre-diabetes
- Keywords
- Chrono-nutrition, Adipose tissue, Skeletal muscle, Insulin sensitivity, Diurnal rhythm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn as the principal investigator moved from the USA to the UK
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 24 Jul 2020 (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.
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| TRE group | Other | Other: 9 hours daily eating windowTime-restricted eating group |
| Control group | Other | Other: 15 hours daily eating windowTime-unrestricted eating group |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- body mass index 30-39.9 kg/m2
- fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
- self-reported habitual eating period > 15 h per day
Key exclusion criteria (21 listed)
- shift worker, recent or expected travel crossing time zones
- fasting >12 h/day more than once a week or vegan
- shift worker, recent or expected travel crossing time zones
- fasting >12 h/day more than once a week or vegan
- > once a week no food intake after 1800 h
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 |
|---|---|---|
| 9 hours daily eating windowParticipants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. | Other | TRE group |
| 15 hours daily eating windowParticipants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks. | Other | Control group |
Primary outcome
Insulin sensitivity
Time frame: 3 months (pre-post intervention)
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
24 h glycemic control
Time frame: 3 months (pre-post intervention)
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Adipose tissue gene expression
Time frame: 3 months (pre-post intervention)
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
1 secondary outcome
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
Time frame: 3 months (pre-post intervention)
Results and safety
The study was stopped early (reason given: Funding withdrawn as the principal investigator moved from the USA to the UK). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9 hours daily eating window and 15 hours daily eating window in people with Obesity and Pre-diabetes, run by University of California, Davis 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 3 inclusion and 21 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: stopped early, as of the sponsor's last update on 22 Aug 2024. 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 was stopped early (reason given: Funding withdrawn as the principal investigator moved from the USA to the UK). Results are not available in the source record.
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?
Insulin sensitivity (time frame: 3 months (pre-post intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.