About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
shift worker
fasting >12 h/day more than once a week
vegan
> once a week no food intake after ~1800 h
Trial design
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.
Healthy Eating
BehavioralParticipants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
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
Trial 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.
Secondary outcomes
Serum insulin concentration using a chemiluminescent assay
Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day.
Serum C-peptide concentration using an ELISA assay
Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day.
Plasma FFA concentration using a colorimetric assay
Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day.
Plasma TG concentration using a colorimetric assay
Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day.
Sponsors and contacts
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