CClinicalTrials.gg
Not yet recruitingNCT07820384RhythmUpdated Sep 15, 2026

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

An interventional study of Time restricted eating and Healthy Eating in Obesity and Prediabetes, sponsored by Cambridge University Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Prediabetes
03

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    TRE Group

    Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.

    Behavioral: Time restricted eating · Behavioral: Healthy Eating

  • Active comparator
    Control Group

    Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.

    Behavioral: Extended eating window · Behavioral: Healthy diet

Interventions

  • BehavioralTime restricted eating

    Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.

  • BehavioralHealthy Eating

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

  • BehavioralExtended eating window

    Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.

  • BehavioralHealthy diet

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

05

What researchers measure

Primary outcomes

  1. Blood glucose concentration using a YSI analyzer

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

    Time frame: 3 months (pre-post intervention)

Secondary outcomes

  1. Serum insulin concentration using a chemiluminescent assay

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

    Time frame: 3 months (pre-post intervention)

  2. Serum C-peptide concentration using an ELISA assay

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

    Time frame: 3 months (pre-post intervention)

  3. Plasma FFA concentration using a colorimetric assay

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

    Time frame: 3 months (pre-post intervention)

  4. Plasma TG concentration using a colorimetric assay

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

    Time frame: 3 months (pre-post intervention)

  5. Serum GLP1 concentration using a V-plex assay

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

    Time frame: 3 months (pre-post intervention)

  6. Serum GIP concentration using a V-plex assay

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

    Time frame: 3 months (pre-post intervention)

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

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

    Time frame: 3 months (pre-post intervention)

06

Study locations

1 site
  • Cambridge Clinical Research Centre
    Cambridge, CB2 0QQ, United Kingdom
07

Registry details

Key details

Study ID
NCT07820384
Lead sponsor
Cambridge University Hospitals NHS Foundation Trust
Responsible party
Maria Chondronikola (Principal Investigator, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Sep 15, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Mar 1, 2031 (estimated)
Completion
May 30, 2031 (estimated)
Last update
Sep 15, 2026

Study contacts

Maria Chondronikola
Contact
mc2425@medschl.cam.ac.uk
+4401223746784

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion