Summary

for people ages 18-75 (full criteria)
at UCSD
study started
estimated completion
Pam Taub, MD(ucsd)

Description

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).

Official Title

Impact of Time-restricted Feeding (TRF) on Glucose Homeostasis and Mitochondrial Function in Patients With Metabolic Syndrome

Details

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.

Keywords

Metabolic Syndrome Pre-Diabetes Time Restricted Eating Circadian Rhythm Glucose Homeostasis Mitochondrial Function Fasting Prediabetic State Syndrome

Eligibility

You can join if…

Open to people ages 18-75

  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

  1. Own a smartphone (Apple iOS or Android OS)
  2. Baseline eating period > 14 hours/day
  3. 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.

You CAN'T join if...

  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).

Location

  • Altman Clinical and Translational Research Institute accepting new patients
    La Jolla California 92093 United States

Lead Scientist

  • Pam Taub, MD (ucsd)
    Dr. Taub is a general cardiologist and assistant professor of medicine at the UC San Diego Health System. She is the director of the Hannah and Gene Step Cardiac Wellness and Rehabilitation Center that will be located in the new UC San Diego Jacobs Medical Center opening in 2016. The mission of the Center is to actively engage patients and the community in prevention of cardiovascular disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04057339
Study Type
Interventional
Last Updated