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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Prediabetes
• Intervention / Treatment: Behavioral: Time restricted eating; Behavioral: Healthy diet; Behavioral: Extended eating window; Behavioral: Healthy Eating

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Chondronikola; Phone Number: +4401223746784; Email: mc2425@medschl.cam.ac.uk

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge Clinical Research Centre
    • Contact: Krishna Chatterjee; Phone Number: +4401223 254800; Email: tdw30@medschl.cam.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 Eating; 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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): May 30, 2031

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Prediabetic State; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Diet, Healthy
• Other Study ID Numbers: 356999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No