The Effect of Time-Restricted Eating in Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorCambridge University Hospitals NHS Foundation Trust
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
shift worker
fasting >12 h/day more than once a week
vegan
> once a week no food intake after ~1800 h
Trial design
Design model
Parallel
Treatments tested in this trial
Time restricted eating
BehavioralParticipants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Extended eating window
BehavioralParticipants 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
BehavioralParticipants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TRE groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions
Trial outcomes
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.
Time frame
3 months (pre-post intervention)Secondary outcomes
1
24 h glycemic control
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Time frame
3 months (pre-post intervention)2
Adipose tissue gene expression
Changes in the expression of genes involved in energy metabolism will be assessed by using quantitative polymerase chain reaction (qPCR).
Time frame
3 months (pre-post intervention)Sponsors and contacts
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Source ClinicalTrials.gov