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NCT Number: NCT05866406

The Effect of Time-Restricted Eating in Cardiometabolic Health

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.

Recruiting

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Clinical Research Center

Cambridge, CB2 0QQ, United Kingdom

Location status: Recruiting

Location contact

Krishna Chatterjee

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time restricted eating

Behavioral

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

Behavioral

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

Behavioral

Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 24 h glycemic control

    Time frame: 3 months (pre-post intervention)

    Changes in plasma glucose concentration will be assessed during a 24 h feeding study.

  2. Adipose tissue gene expression

    Time frame: 3 months (pre-post intervention)

    Changes in the expression of genes involved in energy metabolism will be assessed by using quantitative polymerase chain reaction (qPCR).

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Chondronikola

CONTACT

[email protected]

01223746784

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Acronym: TRE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 19, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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