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NCT Number: NCT07820384

The Effect of Time-Restricted Eating in 24-hour Metabolic Homeostasis and Diurnal Rhythm

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Clinical Research Centre

Cambridge, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • willing and able to give informed consent for participation in the study
  • aged 35-75 years
  • men and women
  • body mass index 27-45 kg/m2
  • fasting plasma glucose 5.6-6.9 mmol/L, or 2h OGTT plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol, 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)
  • type 1 or 2 diabetes
  • sleep disorder (individuals with well-controlled sleep apnoea)
  • eating disorder
  • 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)
  • unable to grant voluntary informed consent or comply with the study instructions
  • individuals with electromedical devices
  • 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.

Healthy Eating

Behavioral

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

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. Blood glucose concentration using a YSI analyzer

    Time frame: 3 months (pre-post intervention)

    Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day.

Secondary outcomes

  1. Serum insulin concentration using a chemiluminescent assay

    Time frame: 3 months (pre-post intervention)

    Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day.

  2. Serum C-peptide concentration using an ELISA assay

    Time frame: 3 months (pre-post intervention)

    Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day.

  3. Plasma FFA concentration using a colorimetric assay

    Time frame: 3 months (pre-post intervention)

    Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day.

  4. Plasma TG concentration using a colorimetric assay

    Time frame: 3 months (pre-post intervention)

    Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day.

  5. Serum GLP1 concentration using a V-plex assay

    Time frame: 3 months (pre-post intervention)

    Changes in 24-h area under the curve for serum GLP1 concentration will be assessed during a 24h metabolic test day.

  6. Serum GIP concentration using a V-plex assay

    Time frame: 3 months (pre-post intervention)

    Changes in 24-h area under the curve for serum GIP concentration will be assessed during a 24h metabolic test day.

  7. Hunger sensation using a standardised questionnaire (visual analog scale)

    Time frame: 3 months (pre-post intervention)

    Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Acronym: Rhythm

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 15, 2026
Registry last updated
Sep 15, 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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