The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome (TIMET)
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|ClinicalTrials.gov Identifier: NCT04057339|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : January 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Pre-Diabetes||Behavioral: Time Restricted Eating + Standard of Care Behavioral: Standard of Care||Not Applicable|
Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.
At the beginning and end of the study (which will be three months in duration), the following parameters will be measured: height, weight, body mass index, percent body fat, waist/hip circumference and blood pressure. Blood sugar levels will be monitored continuously for 2 weeks at a time at the beginning and end of the study using a continuous glucose monitor. Additionally, a dual energy X-ray absorptiometry (DXA) scan will be used to collect information about body composition. Information will be collected about the mitochondria with a muscle biopsy. Participants will use a smartphone application (called myCircadianClock (mCC), developed by the Salk Institute) to keep track of food/beverage intake and will wear a wrist-worn actigraphy device to monitor physical activity levels and sleep.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Influence of Time-restricted Eating (TRE) on Circadian Regulation of Glucose Homeostasis and Mitochondrial Function - The TIMET Study|
|Actual Study Start Date :||April 8, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Placebo Comparator: SOC (Standard of Care)
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Behavioral: Standard of Care
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
Experimental: TRE + SOC
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Behavioral: Time Restricted Eating + Standard of Care
Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
Other Name: Time Restricted Eating
- Change in glucose levels assessed via HbA1c [ Time Frame: Baseline and 14 weeks ]HbA1c (%)
- Change in glycemic parameters [ Time Frame: Baseline and 14 weeks ]Glycemic parameters assessed via fasting glucose, HOMA-IR, Insulin, and continuous glucose monitors (CGM).
- Change in LDL particle number [ Time Frame: Baseline and 14 weeks ]LDL particle number (nmol/L) via NMR lipoprofile
- Change in LDL cholesterol [ Time Frame: Baseline and 14 weeks ]LDL cholesterol (mg/dl)
- Change in HDL cholesterol [ Time Frame: Baseline and 14 weeks ]HDL cholesterol (mg/dl)
- Change in Triglycerides [ Time Frame: Baseline and 14 weeks ]Triglycerides (mg/dl)
- Change in body composition by DXA [ Time Frame: Baseline and 14 weeks ]Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
- Change in hs-CRP [ Time Frame: Baseline and 14 weeks ]High sensitivity C-reactive protein (mg/L)
- Change in mitochondrial structure and gene expression in skeletal muscle [ Time Frame: Baseline and 14 weeks ]Mitochondrial structure and gene expression in skeletal muscle as assessed by skeletal muscle biopsies.
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): NCT04057339
|Contact: David Van, BSfirstname.lastname@example.org|
|Contact: Victoria Green, BS||858-246-2046|
|United States, California|
|Altman Clinical and Translational Research Institute||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Aryana Pazargadi, BS 858-246-2406|
|Principal Investigator: Pam Taub, MD|
|Principal Investigator:||Pam Taub, MD||Associate Professor of Medicine|