- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057339
The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome (TIMET)
Influence of Time-restricted Eating (TRE) on Circadian Regulation of Glucose Homeostasis and Mitochondrial Function - The TIMET Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Van, BS
- Phone Number: 858-246-2342
- Email: ucsdresearchcoordinator@gmail.com
Study Contact Backup
- Name: Justina Nguyen, BS
- Phone Number: 858-246-2046
Study Locations
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California
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La Jolla, California, United States, 92093
- Altman Clinical and Translational Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75 years
- 41 ≥ BMI ≥ 25 AND
Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% < 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in males or < 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥ 12 hour window
- If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period.
Exclusion Criteria:
- Taking insulin within the last 6 months.
- Manifest diabetes, defined as HbA1c > 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
- Known inflammatory and/or rheumatologic disease.
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
- Pregnant or breast-feeding women.
- Shift workers with variable (e.g. nocturnal) hours.
- Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
- Planned travel to a time zone with greater than a 3-hour difference during study period.
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of eating disorder(s).
- History of cirrhosis.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Currently taking any medication that is meant for, or has known effect on, appetite.
- Any history of surgical intervention for weight management.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- A score of >16 on the Epworth Sleepiness Scale (ESS).
- Depression determined by the Beck Depression Inventory (BDI) (unless previously diagnosed and well-controlled).
- Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glucose levels assessed via HbA1c
Time Frame: Baseline and 14 weeks
|
HbA1c (%)
|
Baseline and 14 weeks
|
Change in glycemic parameters
Time Frame: Baseline and 14 weeks
|
Glycemic parameters assessed via fasting glucose (mg/dL), HOMA-IR, Insulin (mIU/L), and continuous glucose monitors (CGM).
|
Baseline and 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in LDL particle number
Time Frame: Baseline and 14 weeks
|
LDL particle number (nmol/L) via NMR lipoprofile
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Baseline and 14 weeks
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Change in LDL cholesterol
Time Frame: Baseline and 14 weeks
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LDL cholesterol (mg/dl)
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Baseline and 14 weeks
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Change in HDL cholesterol
Time Frame: Baseline and 14 weeks
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HDL cholesterol (mg/dl)
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Baseline and 14 weeks
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Change in Triglycerides
Time Frame: Baseline and 14 weeks
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Triglycerides (mg/dl)
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Baseline and 14 weeks
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Change in body composition by DXA
Time Frame: Baseline and 14 weeks
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Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
|
Baseline and 14 weeks
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Change in hs-CRP
Time Frame: Baseline and 14 weeks
|
High sensitivity C-reactive protein (mg/L)
|
Baseline and 14 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 14 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pam Taub, MD, Associate Professor of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181088
- 1R01DK118278-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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