Effects of Time-Restricted Eating on Cardiometabolic Health
The Effect of Time-Restricted Eating in Cardiometabolic Health
This study is testing if eating only during a 9-hour window each day can help people with obesity and prediabetes improve their heart and metabolic health over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT05866406 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of time-restricted eating (TRE) on cardiometabolic health in individuals with obesity and prediabetes. Participants will follow a 9-hour eating window for 12 weeks without altering their body weight. The study aims to assess key metabolic outcomes, including insulin sensitivity and metabolic homeostasis, to better understand how TRE may influence cardiovascular disease risk factors. By comparing these outcomes, the trial seeks to clarify the potential benefits of TRE in improving metabolic health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25-75 with a body mass index between 27-45 kg/m2 and diagnosed with prediabetes.
Not a fit: Patients with clinical diagnoses of diabetes, eating disorders, or significant weight fluctuations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary strategy to improve metabolic health and reduce cardiovascular disease risk in patients with obesity and prediabetes.
How similar studies have performed: While there is limited research on time-restricted eating in humans, preliminary studies suggest potential benefits, indicating this approach is promising yet still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Cambridge
- Cambridge Clinical Research Center — Cambridge, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Maria Chondronikola
- Email: mc2425@medschl.cam.ac.uk
- Phone: 01223746784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.