The Effect of Time-Restricted Eating in Cardiometabolic Health
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|ClinicalTrials.gov Identifier: NCT04484987|
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : June 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pre-diabetes||Other: 9 hours daily eating window Other: 15 hours daily eating window||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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.
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.
- 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.
- 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.
- 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.
- Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells [ Time Frame: 3 months (pre-post intervention) ]We will evaluate changes in clock gene expression
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
|Contact: Maria Chondronikola, PhDfirstname.lastname@example.org|
|Contact: Romina Sacchi, MSemail@example.com|
|United States, California|
|University of California, Davis||Recruiting|
|Davis, California, United States, 95616-5398|
|Contact: Romina Sacchi, MS 530-754-1766 firstname.lastname@example.org|
|Principal Investigator: Maria Chondronikola, PhD|