An interventional study of Time restricted eating and Healthy Eating in Obesity and Prediabetes, sponsored by Cambridge University Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Prevention
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.
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.
Behavioral: Time restricted eating · Behavioral: Healthy Eating
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Behavioral: Extended eating window · Behavioral: Healthy diet
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.
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.
Time frame: 3 months (pre-post intervention)
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.
Time frame: 3 months (pre-post intervention)
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.
Time frame: 3 months (pre-post intervention)
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.
Time frame: 3 months (pre-post intervention)
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.
Time frame: 3 months (pre-post intervention)
Serum GLP1 concentration using a V-plex assay
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)
Serum GIP concentration using a V-plex assay
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)
Hunger sensation using a standardised questionnaire (visual analog scale)
Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety
Time frame: 3 months (pre-post intervention)
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust