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

VA Greater Los Angeles Healthcare System

Status: Not yet enrolling

Conditions: NAFLD (Nonalcoholic Fatty Liver Disease)

Treatments: Device: continuous glucose monitor (CGM); Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF); Device: The integrated sweat sensor and vascular sensor (wearable)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06932289

1832799-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 4 patient groups

Diet 1 (one of the three kinds of diets)

Active Comparator group

Description:

participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.

Treatment:

Device: The integrated sweat sensor and vascular sensor (wearable)

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

Device: continuous glucose monitor (CGM)

Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)

Active Comparator group

Description:

participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.

Treatment:

Device: The integrated sweat sensor and vascular sensor (wearable)

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

Device: continuous glucose monitor (CGM)

Diet 3 (the final remaining diet)

Active Comparator group

Description:

participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.

Treatment:

Device: The integrated sweat sensor and vascular sensor (wearable)

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

Device: continuous glucose monitor (CGM)

Habitual diet as a baseline

Experimental group

Description:

All participants will consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.

Treatment:

Device: The integrated sweat sensor and vascular sensor (wearable)

Device: continuous glucose monitor (CGM)