The Effect of Time-Restricted Eating in Cardiometabolic Health

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · May 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a dietary approach called time-restricted eating (TRE) on the health of people with obesity and prediabetes. TRE means that participants will eat all their meals within a specific window of 9 hours each day, while fasting for the remaining 15 hours. The goal is to see if this eating pattern can improve important health markers related to heart disease, such as insulin sensitivity and overall metabolism, without requiring participants to lose weight.

To participate in the study, individuals need to be between 25 and 75 years old, have a body mass index (BMI) between 27 and 45, and have certain blood sugar levels indicating prediabetes. Participants will need to commit to following the TRE schedule for 12 weeks and will undergo various health tests to measure their progress. It's important to note that some people, such as those with diabetes, sleep disorders, or certain medical conditions, will not be eligible for this study. This trial could provide valuable insights into how changing eating patterns can benefit people dealing with obesity and prediabetes.

Gender

ALL

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