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

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: Obesity; PreDiabetes
• Intervention / Treatment: Behavioral: Time restricted eating; Behavioral: Healthy diet; Behavioral: Extended eating window

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Chondronikola; Phone Number: 01223746784; Email: mc2425@medschl.cam.ac.uk

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Cambridge Clinical Research Center
    • Contact: Krishna Chatterjee; Email: tdw30@medschl.cam.ac.uk

Participation Criteria

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

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 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	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	Changes in plasma glucose concentration will be assessed during a 24 h feeding study.	3 months (pre-post intervention)
Adipose tissue gene expression	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

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

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): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• 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