The Effect of Time-Restricted Eating in Cardiometabolic Health

NCT ID: NCT05866406

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2028-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time restricted eating

Intervention Type: 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.

Healthy diet

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Extended eating window

Intervention Type: 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.

Healthy diet

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Healthy diet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Maria Chondronikola

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cambridge Clinical Research Center

Cambridge, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Maria Chondronikola

Role: CONTACT

mc2425@medschl.cam.ac.uk

01223746784

Facility Contacts

Krishna Chatterjee

Role: primary

tdw30@medschl.cam.ac.uk

Other Identifiers

322459

Identifier Type: -

Identifier Source: org_study_id