This study is not yet accepting patients

Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions

a study on Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Tzung Hsiai, M.D., Ph.D. (ucla)
Headshot of Tzung Hsiai
Tzung Hsiai

Description

Summary

It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.

Details

The investigators will conduct a randomized, controlled crossover intervention study. The investigators will enroll 54 participants, aged >18 years, BMI >25 kg/m2 with metabolic syndrome. During the first phase, all participants will consume their habitual diet for 2 weeks to establish baseline. Then participants will be randomized to either a Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF) for 14 days with 2 weeks washout between the different diets. The wearable system will monitor basal levels and the changes for glucose, cholesterol, TG, and NO through sweat analysis and HR, HRV, and PWV for carotid arterial stiffness during each diet intervention.

Keywords

NAFLD (Nonalcoholic Fatty Liver Disease), NAFLD, metabolic responses, mixed meal challenge, Liver Diseases, Fatty Liver, Non-alcoholic Fatty Liver Disease, Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), The integrated sweat sensor and vascular sensor (wearable), continuous glucose monitor (CGM), Diet 1 (one of the three kinds of diets), Diet 2 (one of the two remaining kinds of diets, excluding Diet 1), Diet 3 (the final remaining diet)

Eligibility

You can join if…

Open to people ages 18-55

  • United States Veterans
  • Male or female, age 18-55 years at the time of signing informed consent.
  • at least 2 of the following: waist circumference > 40" for men and 35" for women, FBS >100 mg/dl, triglycerides > 150 but < 500 mg/dL, HDL < 40 mg/dL, Pre- hypertension or hypertension (BP>120/80 mmHg but <150/90 mmHg)

You CAN'T join if...

  • History of diabetes require medications
  • History of alcohol intake ≥ 20g/day
  • History of cirrhosis
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of <30 mL/min/1.73 m2
  • History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
  • Any unstable medical conditions or terminal diagnosis.
  • Any participant who is unwilling to sign an informed consent form will not be admitted into the study.

Location

  • Va Greater Los Angeles Healthcare System
    Los Angeles California 90073 United States

Lead Scientist at University of California Health

  • Tzung Hsiai, M.D., Ph.D. (ucla)
    Tzung Hsiai, Ph.D., previously held the Maud Cady Guthman Chair in Cardiology (7/1/2018 - 6/30/2023).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Greater Los Angeles Healthcare System
ID
NCT06932289
Study Type
Interventional
Participants
Expecting 54 study participants
Last Updated