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The Effect of Time-Restricted Eating in Cardiometabolic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484987
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Chondronikola, University of California, Davis

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

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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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 20, 2021
Estimated Study Completion Date : May 31, 2021

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484987


Contacts
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Contact: Maria Chondronikola, PhD 530-754-1977 mchondr@ucdavis.edu
Contact: Romina Sacchi, MS 5307541766 rsacchi@ucdavis.edu

Locations
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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
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Responsible Party: Maria Chondronikola, Assistant Professor, Department of Nutrition, University of California, Davis
ClinicalTrials.gov Identifier: NCT04484987    
Other Study ID Numbers: 1521859
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
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.

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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 Maria Chondronikola, University of California, Davis:
Chrono-nutrition
Adipose tissue
Skeletal muscle
Insulin sensitivity
Diurnal rhythm
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases