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

N/ANot Yet RecruitingNCT07820384

Cambridge University Hospitals NHS Foundation Trust26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Obesity Prediabetes

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.