Study Stopped
Funding withdrawn as the principal investigator moved from the USA to the UK
The Effect of Time-Restricted Eating in Cardiometabolic Health
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Nov 2020
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedAugust 22, 2024
November 1, 2023
2.1 years
July 17, 2020
August 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Insulin sensitivity
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
3 months (pre-post intervention)
24 h glycemic control
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
3 months (pre-post intervention)
Adipose tissue gene expression
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
3 months (pre-post intervention)
Secondary Outcomes (1)
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
3 months (pre-post intervention)
Study Arms (2)
TRE group
OTHERTime-restricted eating group
Control group
OTHERTime-unrestricted eating group
Interventions
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 15-hour window for 12 weeks.
Eligibility Criteria
You may qualify if:
- body mass index 30-39.9 kg/m2
- fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
- self-reported habitual eating period \> 15 h per day
You may not qualify if:
- shift worker, recent or expected travel crossing time zones
- fasting \>12 h/day more than once a week or vegan
- shift worker, recent or expected travel crossing time zones
- fasting \>12 h/day more than once a week or vegan
- \> once a week no food intake after 1800 h
- habitually waking up before 0400 h and sleeping before 2230 h
- ≥ 150 min per week of structured exercise
- unstable weight (\>5% change the last 2 months)
- type 2 diabetes or other major chronic disease
- sleep disorder
- cancer in last 5 years
- conditions that render subject unable to complete all testing procedures
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis
Davis, California, 95616-5398, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 24, 2020
Study Start
November 20, 2020
Primary Completion
December 30, 2022
Study Completion
May 20, 2024
Last Updated
August 22, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon publication of the study data.
The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.