The Effect of Time-Restricted Eating in Cardiometabolic Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Pre-diabetes
• Intervention / Treatment: Other: 9 hours daily eating window; Other: 15 hours daily eating window

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Chondronikola, PhD; Phone Number: 530-754-1977; Email: mchondr@ucdavis.edu
• Study Contact Backup: Name: Romina Sacchi, MS; Phone Number: 5307541766; Email: rsacchi@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616-5398
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• menopause
• individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
• gastrointestinal or bariatric surgery
• unable to grant voluntary informed consent or comply with the study instructions
• individuals who are not yet adults (infants, children, teenagers)
• prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TRE group; Time-restricted eating group	Other: 9 hours daily eating window; Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Other: Control group; Time-unrestricted eating group	Other: 15 hours daily eating window; Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells	We will evaluate changes in clock gene expression	3 months (pre-post intervention)

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Insulin sensitivity; Adipose tissue; Skeletal muscle; Chrono-nutrition; Diurnal rhythm
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 1521859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon publication of the study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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