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The Influence of Time-Restricted Eating in Patients Metabolic Syndrome (TIMET)

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ClinicalTrials.gov Identifier: NCT04057339
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Salk Institute for Biological Studies
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE August 15, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Change in fasting glucose [ Time Frame: Baseline and 14 weeks ]
    Fasting glucose (mg/dl)
  • Change in fasting glucose levels [ Time Frame: Baseline and 14 weeks ]
    Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline and end of intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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 % fat mass [ Time Frame: Baseline and 14 weeks ]
    Fat mass as measured 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 HbA1c [ Time Frame: Baseline and 14 weeks ]
    HbA1c (%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Influence of Time-Restricted Eating in Patients Metabolic Syndrome
Official Title  ICMJE Impact of Time-restricted Feeding (TRF) on Glucose Homeostasis and Mitochondrial Function in Patients With Metabolic Syndrome
Brief Summary In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 10 hour eating window for 12 weeks (TRE).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Pre-Diabetes
Intervention  ICMJE
  • Behavioral: Time Restricted Feeding + Standard of Care
    Participants in this arm will adhere to a daily, consistent 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
  • Behavioral: Standard of Care
    Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard of Care
  • Experimental: TRE + SOC
    Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 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.
    Intervention: Behavioral: Time Restricted Feeding + Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-75 years
  2. BMI > 25 AND
  3. Metabolic syndrome, as defined as presence of 3 or more of the following criteria:

    Elevated fasting plasma glucose ≥ 100 mg/dL 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

  4. Own a smartphone (Apple iOS or Android OS)
  5. Baseline eating period > 14 hours/day
  6. 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:

  1. Taking insulin within the last 6 months.
  2. Manifest diabetes, defined as HbA1c > 6.5%, or diagnosis of diabetes.
  3. Known inflammatory and/or rheumatologic disease.
  4. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
  5. Pregnant or breast-feeding women.
  6. Shift workers with variable (e.g. nocturnal) hours.
  7. Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
  8. Planned international travel during study period.
  9. 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)).
  10. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
  11. 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).
  12. History of adrenal disease.
  13. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
  14. Known history of type I diabetes.
  15. History of eating disorder.
  16. History of cirrhosis.
  17. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
  18. History of HIV/AIDS.
  19. Currently enrolled in a weight-loss or weight-management program.
  20. On a special or prescribed diet for other reasons (e.g. Celiac disease).
  21. Currently taking any medication that is meant for, or has known effect on, appetite.
  22. Any history of surgical intervention for weight management.
  23. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
  24. A score of >16 on the Epworth Sleepiness Scale (ESS).
  25. Depression determined by the Beck Depression Inventory (BDI).
  26. Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hannah Lo, BS 8582462510 hclo@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04057339
Other Study ID Numbers  ICMJE 181088
1R01DK118278-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pam Taub, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Salk Institute for Biological Studies
Investigators  ICMJE
Principal Investigator: Pam Taub, MD Associate Professor of Medicine
PRS Account University of California, San Diego
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP