ObesityTRENCT05866406
The Effect of Time-Restricted Eating in Cardiometabolic Health
A study testing Time restricted eating, Extended eating window and Healthy diet in people with Obesity and PreDiabetes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, PreDiabetes
- What is being tested?
- Time restricted eating, Extended eating window and Healthy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be able to grant voluntary informed consent and comply with the study instructions
- aged 25-75 years
- men and women
- body mass index 27-45 kg/m2
- fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
- self-reported habitual eating period ≥ 13 h per day
Who cannot join
- shift worker
- fasting >12 h/day more than once a week
- vegan
- > once a week no food intake after ~1800 h
- habitually waking up before ~0400 h and sleeping before ~2100 h
- unstable weight (>5% change the last 2 months)
Show all 18Show fewer
- Clinical diagnosis of type 1 or 2 diabetes
- Clinical diagnosis of sleep disorder
- Clinical diagnosis of eating disorder
- Clinical diagnosis of cancer in last 5 years
- conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
- 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
- gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
- individuals with electromedical devises
- prisoners
- alcohol abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge Clinical Research Center
Cambridge, CB2 0QQ
Krishna Chatterjee, tdw30@medschl.cam.ac.uk
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, PreDiabetes
- Being tested
- Time restricted eating, Extended eating window, Healthy diet
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Extended eating windowBehavioural
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Healthy dietBehavioural
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
| Study group | Role | What they receive |
|---|---|---|
| TRE group | Experimental | Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. Receives: Behavioral: Time restricted eating; Behavioral: Healthy diet |
| Control group | Active comparator | Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks. Receives: Behavioral: Extended eating window; Behavioral: Healthy diet |
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)
Secondary outcomes (2)
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 quantitative polymerase chain reaction (qPCR).
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 posted19 May 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Chondronikola, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866406
- Sponsor's protocol ID
- 322459
- Acronym
- TRE
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. 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
- NCT05866406
- Acronym / sponsor ID
- TRE / 322459
- Conditions
- Obesity, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 May 2023 (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
| Arm | Type | Receives |
|---|---|---|
| TRE group | Experimental | Behavioral: Time restricted eating, Behavioral: Healthy dietParticipants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. |
| Control group | Active comparator | Behavioral: Extended eating window, Behavioral: Healthy dietParticipants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- must be able to grant voluntary informed consent and comply with the study instructions
- aged 25-75 years
- men and women
- body mass index 27-45 kg/m2
- fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
Key exclusion criteria (18 listed)
- shift worker
- fasting >12 h/day more than once a week
- vegan
- > once a week no food intake after ~1800 h
- habitually waking up before ~0400 h and sleeping before ~2100 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 |
|---|---|---|
| Time restricted eatingParticipants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. | Behavioural | TRE group |
| Extended eating windowParticipants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks. | Behavioural | Control group |
| Healthy dietParticipants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention. | Behavioural | Control group, TRE 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.
2 secondary outcomes
24 h glycemic control
Time frame: 3 months (pre-post intervention)
Adipose tissue gene expression
Time frame: 3 months (pre-post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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.
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, Extended eating window and Healthy diet in people with Obesity and PreDiabetes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 18 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Chondronikola (01223746784, mc2425@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 3 months (pre-post intervention)). 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 28 May 2026.