Clinical trial NCT06932289: Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
Official title: Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NAFLD (Nonalcoholic Fatty Liver Disease)
Keywords: NAFLD
metabolic responses
mixed meal challenge
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2025-04-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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 criteria: 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.

Primary outcomes:
measure: Concentration of glucose
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Concentration of cholesterol
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Concentration of triacylglycerol (TG)
timeFrame: From enrollment to the end of measurement at 12 weeks]
measure: Concentration of Nitric oxide (NO)
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Measurement of heart rate (HR)
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Measurement of heart rate variability (HRV)
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Measurement of pulse wave velocity (PWV)
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Body weight
timeFrame: From enrollment to the end of measurement at 12 weeks
measure: Height
timeFrame: From enrollment to the end of measurement at 12 weeks
Secondary outcomes:
measure: BMI
timeFrame: From enrollment to the end of measurement at 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Va Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: VAGLAHS and UCLA
name: Tzung Hsiai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: