An interventional study of Time restricted eating and Healthy Eating in Obesity and Prediabetes, sponsored by Cambridge University Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Prevention
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no food intake during the rest of the day. In animals, TRE improves metabolic function without caloric restriction. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. This study is a randomized controlled trial in people with obesity and prediabetes/insulin resistance. The overall goal of the study is to determine the effect of 9 h TRE for 12 weeks on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): The goal of this study is to answer the following questions: 1) 24-hour metabolic homeostasis 2) 24h diurnal rhythm and appetite regulation.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 26 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Behavioral: Time restricted eating · Behavioral: Healthy Eating
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Behavioral: Extended eating window · Behavioral: Healthy diet
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Blood glucose concentration using a YSI analyzer
Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Serum insulin concentration using a chemiluminescent assay
Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Serum C-peptide concentration using an ELISA assay
Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Plasma FFA concentration using a colorimetric assay
Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Plasma TG concentration using a colorimetric assay
Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Serum GLP1 concentration using a V-plex assay
Changes in 24-h area under the curve for serum GLP1 concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Serum GIP concentration using a V-plex assay
Changes in 24-h area under the curve for serum GIP concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Hunger sensation using a standardised questionnaire (visual analog scale)
Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety
Time frame: 3 months (pre-post intervention)
Start is estimated for Sep 2026; primary completion for Mar 2031, 53 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 53 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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