Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 2 of 7 for:    Pam taub

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

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: 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

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).

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Pre-Diabetes Behavioral: Time Restricted Feeding + Standard of Care Behavioral: Standard of Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Time-restricted Feeding (TRF) on Glucose Homeostasis and Mitochondrial Function in Patients With Metabolic Syndrome
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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.
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.

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.
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




Primary Outcome Measures :
  1. Change in fasting glucose [ Time Frame: Baseline and 14 weeks ]
    Fasting glucose (mg/dl)

  2. 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


Secondary Outcome Measures :
  1. Change in LDL particle number [ Time Frame: Baseline and 14 weeks ]
    LDL particle number (nmol/L) via NMR lipoprofile

  2. Change in LDL cholesterol [ Time Frame: Baseline and 14 weeks ]
    LDL cholesterol (mg/dl)

  3. Change in HDL cholesterol [ Time Frame: Baseline and 14 weeks ]
    HDL cholesterol (mg/dl)

  4. Change in Triglycerides [ Time Frame: Baseline and 14 weeks ]
    Triglycerides (mg/dl)

  5. Change in % fat mass [ Time Frame: Baseline and 14 weeks ]
    Fat mass as measured by dual-energy X-ray absorptiometry (DXA)

  6. Change in hs-CRP [ Time Frame: Baseline and 14 weeks ]
    high sensitivity C-reactive protein (mg/L)

  7. Change in HbA1c [ Time Frame: Baseline and 14 weeks ]
    HbA1c (%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT04057339


Contacts
Layout table for location contacts
Contact: Hannah Lo, BS 8582462510 hclo@ucsd.edu

Locations
Layout table for location information
United States, California
Altman Clinical and Translational Research Institute Recruiting
La Jolla, California, United States, 92093
Contact: Hannah Lo, BS    858-246-2510    hclo@ucsd.edu   
Principal Investigator: Pam Taub, MD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Salk Institute for Biological Studies
Investigators
Layout table for investigator information
Principal Investigator: Pam Taub, MD Associate Professor of Medicine

Layout table for additonal information
Responsible Party: Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04057339    
Other Study ID Numbers: 181088
1R01DK118278-01 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pam Taub, MD, University of California, San Diego:
Time Restricted Eating
Circadian Rhythm
Glucose Homeostasis
Mitochondrial Function
Fasting
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Prediabetic State
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases