The Effect of Time-Restricted Eating in 24-hour Metabolic Homeostasis and Diurnal Rhythm

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
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 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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Time restricted eating

    Behavioral

    Participants 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

    Behavioral

    Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.

  • Extended eating window

    Behavioral

    Participants 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

    Behavioral

    Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: TRE GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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