Cambridge Clinical Research Centre
Cambridge, CB2 0QQ, United Kingdom
NCT Number: NCT07820384
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.
Trial opening soon.
Get Notified35 year–75 year
All sexes
Interventional
Not applicable
Cambridge, CB2 0QQ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Time frame: 3 months (pre-post intervention)
Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in 24-h area under the curve for serum GLP1 concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in 24-h area under the curve for serum GIP concentration will be assessed during a 24h metabolic test day.
Time frame: 3 months (pre-post intervention)
Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety
Trial opening soon.
Get NotifiedCambridge University Hospitals NHS Foundation Trust
Other
Acronym: Rhythm
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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