The Effect of Time-Restricted Eating in Cardiometabolic Health

• ClinicalTrials.gov Identifier: NCT04484987
• Recruitment Status: Recruiting
• First Posted: July 24, 2020
• Last Update Posted: June 6, 2022
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Pre-diabetes	Other: 9 hours daily eating window; Other: 15 hours daily eating window	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of Time-Restricted Eating in Cardiometabolic Health
• Actual Study Start Date: November 20, 2020
• Estimated Primary Completion Date: May 20, 2025
• Estimated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Insulin sensitivity [ Time Frame: 3 months (pre-post intervention) ]
   Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
2. 24 h glycemic control [ Time Frame: 3 months (pre-post intervention) ]
   Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
3. Adipose tissue gene expression [ Time Frame: 3 months (pre-post intervention) ]
   Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.

Secondary Outcome Measures :

1. Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells [ Time Frame: 3 months (pre-post intervention) ]
   We will evaluate changes in clock gene expression

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Maria Chondronikola, PhD; 530-754-1977; mchondr@ucdavis.edu

Contact: Romina Sacchi, MS; 5307541766; rsacchi@ucdavis.edu

Locations

United States, California

University of California, Davis; Recruiting

Davis, California, United States, 95616-5398

Contact: Romina Sacchi, MS 530-754-1766 rsacchi@ucdavis.edu

Principal Investigator: Maria Chondronikola, PhD

Sponsors and Collaborators

University of California, Davis

More Information

Additional Information:

Learn more or sign up for the study here! 

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04484987
• Other Study ID Numbers: 1521859
• First Posted: July 24, 2020
• Last Update Posted: June 6, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: Upon publication of the study data.

• 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

Keywords provided by University of California, Davis:

Chrono-nutrition; Adipose tissue; Skeletal muscle; Insulin sensitivity; Diurnal rhythm

Additional relevant MeSH terms:

Prediabetic State; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases