NCT05866406Recruiting
The Effect of Time-Restricted Eating in Cardiometabolic Health
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 10 May 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Diseases
- Obesity
- NCT number
- NCT05866406
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Nov 2023 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
Other illness
- 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)
Other
- 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)
- pregnant or lactating
- individuals with electromedical devises
- prisoners
- alcohol abuse
Who the study is looking for
- 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
Age in the registry: 25 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge Clinical Research Center Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.