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

NCT07820384 | Not Yet Recruiting

• 1 other identifier: 356999
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes; Obesity

Outcome Measures

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.

  3 months (pre-post intervention)

Secondary Outcomes (7)

• Serum insulin concentration using a chemiluminescent assay

  3 months (pre-post intervention)

• Serum C-peptide concentration using an ELISA assay

  3 months (pre-post intervention)

• Plasma FFA concentration using a colorimetric assay

  3 months (pre-post intervention)

• Plasma TG concentration using a colorimetric assay

  3 months (pre-post intervention)

• Serum GLP1 concentration using a V-plex assay

  3 months (pre-post intervention)

Study Arms (2)

TRE Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

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.

TRE Group

Healthy Eating BEHAVIORAL

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

TRE Group

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.

Control Group

Healthy diet BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge Clinical Research Centre

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Maria Chondronikola

CONTACT

+4401223746784; mc2425@medschl.cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: September 15, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): May 30, 2031
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

GB (1)