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The Effect of Time-Restricted Eating in Cardiometabolic Health

Sponsor: Cambridge University Hospitals NHS Foundation Trust

NCT ID: NCT05866406

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Time restricted eating (behavioural), Extended eating window (behavioural), Healthy diet (behavioural)
How long the study runs
Study runs about 57 months (dates as stated)
About the drug or intervention
Time restricted eating — behavioural: 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 window — behavioural: 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 diet — behavioural: Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
25 Years to 75 Years
Who
All
Number of participants
100
Started
2023-11-01
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • NA - 100 participants
  • • 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

Who can take part?

  • • Ages 25 Years to 75 Years
  • • Diagnosed with obesity

Where?

  • • Cambridge - Cambridge Clinical Research Center

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

ObesityPreDiabetes

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓must be able to grant voluntary agreement to take part and comply with the study instructions
  • ✓aged 25-75 years
  • ✓men and women
  • ✓body mass index 27-45 kg/m2
  • ✓self-reported habitual eating period ≥ 13 h per day

Who cannot take part

  • ✗shift worker
  • ✗fasting \>12 h/day more than once a week
  • ✗\> 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)
See the full 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 Is This Study? (1 UK site)

Cambridge Clinical Research Center

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Krishna Chatterjeetdw30@medschl.cam.ac.uk

How to Get in Touch

Maria Chondronikola

Sponsor contact

CONTACT

01223746784 mc2425@medschl.cam.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05