NCT06932289

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF)	Participants will be randomized to either Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF).
DEVICE	The integrated sweat sensor and vascular sensor (wearable)	The integrated sweat sensor and vascular sensor will be worn of each diet period.
DEVICE	continuous glucose monitor (CGM)	A continuous glucose monitor (CGM) will be placed on the patients during each diet period.

Timeline

• Start date: 2025-05-01
• Primary completion: 2029-04-30
• Completion: 2029-05-01
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study