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The Effect of Time-Restricted Eating in Cardiometabolic Health (TRE)

Primary Purpose

Obesity, PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Time restricted eating
Extended eating window
Healthy diet
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73 self-reported habitual eating period ≥ 13 h per day Exclusion Criteria: shift worker fasting >12 h/day more than once a week vegan > once a week no food intake after ~1800 h habitually waking up before ~0400 h and sleeping before ~2100 h unstable weight (>5% change the last 2 months) Clinical diagnosis of type 1 or 2 diabetes Clinical diagnosis of sleep disorder Clinical diagnosis of eating disorder Clinical diagnosis of cancer in last 5 years conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study) use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.) smoking and illegal drug use pregnant or lactating gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy) individuals with electromedical devises prisoners alcohol abuse

Sites / Locations

  • Cambridge Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRE group

Control group

Arm Description

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 assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.

Outcomes

Primary Outcome Measures

Insulin sensitivity
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.

Secondary Outcome Measures

24 h glycemic control
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Adipose tissue gene expression
Changes in the expression of genes involved in energy metabolism will be assessed by using quantitative polymerase chain reaction (qPCR).

Full Information

First Posted
May 10, 2023
Last Updated
August 31, 2023
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05866406
Brief Title
The Effect of Time-Restricted Eating in Cardiometabolic Health
Acronym
TRE
Official Title
The Effect of Time-Restricted Eating in Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, PreDiabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRE group
Arm Type
Experimental
Arm Description
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating
Intervention Description
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Extended eating window
Intervention Description
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Healthy diet
Intervention Description
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
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 Outcome Measure Information:
Title
24 h glycemic control
Description
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Time Frame
3 months (pre-post intervention)
Title
Adipose tissue gene expression
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73 self-reported habitual eating period ≥ 13 h per day Exclusion Criteria: shift worker fasting >12 h/day more than once a week vegan > once a week no food intake after ~1800 h habitually waking up before ~0400 h and sleeping before ~2100 h unstable weight (>5% change the last 2 months) Clinical diagnosis of type 1 or 2 diabetes Clinical diagnosis of sleep disorder Clinical diagnosis of eating disorder Clinical diagnosis of cancer in last 5 years conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study) use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.) smoking and illegal drug use pregnant or lactating gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy) individuals with electromedical devises prisoners alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Chondronikola
Phone
01223746784
Email
mc2425@medschl.cam.ac.uk
Facility Information:
Facility Name
Cambridge Clinical Research Center
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Chatterjee
Email
tdw30@medschl.cam.ac.uk

12. IPD Sharing Statement

Learn more about this trial

The Effect of Time-Restricted Eating in Cardiometabolic Health

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