| Registry | NCT06932289 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, basic science |
| Enrollment | 54 (Estimated) |
| Sponsor | VA Greater Los Angeles Healthcare System (Fed) |
| Conditions | NAFLD (Nonalcoholic Fatty Liver Disease) |
| Interventions | 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) (Dietary supplement, device) |
| Dates | start 2025-05-01 (estimated), primary completion 2029-04-30 (estimated), completion 2029-05-01 (estimated), first posted 2025-04-17, last updated 2025-04-17 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for NAFLD (Nonalcoholic Fatty Liver Disease) All trials of Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) All trials of The integrated sweat sensor and vascular sensor (wearable)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diet 1 (one of the three kinds of diets) | Active comparator | 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); Device: continuous glucose monitor (CGM) | 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. |
| Diet 2 (one of the two remaining kinds of diets, excluding Diet 1) | Active comparator | 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); Device: continuous glucose monitor (CGM) | 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. |
| Diet 3 (the final remaining diet) | Active comparator | 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); Device: continuous glucose monitor (CGM) | 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. |
| Habitual diet as a baseline | Experimental | Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM) | 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. |
Sex: All, ages: 18 Years to 55 Years, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Va Greater Los Angeles Healthcare System | Los Angeles, California | United States |