The Effect of Time-Restricted Eating in Cardiometabolic Health

NCT05866406 | Recruiting

• 1 other identifier: 322459
• Study Type: interventional
• Target: 100
• 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 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.

Conditions

Obesity; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 24 h glycemic control

  3 months (pre-post intervention)

• Adipose tissue gene expression

  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 diet

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

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; TRE group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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)
• 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)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge Clinical Research Center

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

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

01223746784; 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: May 10, 2023
• First Posted: May 19, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-01

Locations

GB (1)