Clinical trial NCT05866406: The Effect of Time-Restricted Eating in Cardiometabolic Health
Official title: The Effect of Time-Restricted Eating in Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
PreDiabetes
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 3 months (pre-post intervention)
Secondary outcomes:
measure: 24 h glycemic control
timeFrame: 3 months (pre-post intervention)
measure: Adipose tissue gene expression
timeFrame: 3 months (pre-post intervention)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Clinical Research Center
Study officials:
References: