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Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions | Clinical Trials | Clareo Health

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

NCT06932289•VA Greater Los Angeles Healthcare System

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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)

Exclusion Criteria

•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.

Locations (1)

Va Greater Los Angeles Healthcare System

Los Angeles, California, United States

Key Dates

Start Date

May 1, 2025

Primary Completion Date

April 30, 2029

Completion Date

May 1, 2029

Last Updated

April 17, 2025

Enrollment

ESTIMATED participants

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF)

DIETARY_SUPPLEMENT

The integrated sweat sensor and vascular sensor (wearable)

DEVICE

continuous glucose monitor (CGM)

DEVICE

Contacts

Tzung Hsiai, M.D., Ph.D.

CONTACT

310-478-3711 thsiai@mednet.ucla.edu

Peng Zhao, M.D., Ph.D.

CONTACT

310-279-0248 pengzhao@mednet.ucla.edu

Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism

NCT04395950

NASH (Nonalcoholic Steatohepatitis)NAFLD (Nonalcoholic Fatty Liver Disease)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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