The Effect of Time-Restricted Eating in Cardiometabolic Health (TRE)

May 27, 2026 updated by: Maria Chondronikola, Cambridge University Hospitals NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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: Healthy diet
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
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: Healthy diet
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Behavioral: Extended 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months (pre-post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months (pre-post intervention)
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).
3 months (pre-post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322459

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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