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

NCT06932289 — Not applicable, Not yet recruiting, 54 participants, VA Greater Los Angeles Healthcare System

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RegistryNCT06932289
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, basic science
Enrollment54 (Estimated)
SponsorVA Greater Los Angeles Healthcare System (Fed)
ConditionsNAFLD (Nonalcoholic Fatty Liver Disease)
InterventionsMediterranean 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)
Datesstart 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
Locations1 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)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Diet 1 (one of the three kinds of diets)Active comparatorDietary 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 comparatorDietary 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 comparatorDietary 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 baselineExperimentalDevice: 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.
  • Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) (Dietary supplement): Participants will be randomized to either Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF).
  • The integrated sweat sensor and vascular sensor (wearable) (Device): The integrated sweat sensor and vascular sensor will be worn of each diet period.
  • continuous glucose monitor (CGM) (Device): A continuous glucose monitor (CGM) will be placed on the patients during each diet period.

+Outcome measures

Primary outcomes

  • Concentration of glucose [From enrollment to the end of measurement at 12 weeks]: The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism
  • Concentration of cholesterol [From enrollment to the end of measurement at 12 weeks]: The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
  • Concentration of triacylglycerol (TG) [From enrollment to the end of measurement at 12 weeks]]: The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
  • Concentration of Nitric oxide (NO) [From enrollment to the end of measurement at 12 weeks]: The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
  • Measurement of heart rate (HR) [From enrollment to the end of measurement at 12 weeks]: The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
  • Measurement of heart rate variability (HRV) [From enrollment to the end of measurement at 12 weeks]: The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
  • Measurement of pulse wave velocity (PWV) [From enrollment to the end of measurement at 12 weeks]: The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness.
  • Body weight [From enrollment to the end of measurement at 12 weeks]: The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI.
  • Height [From enrollment to the end of measurement at 12 weeks]: The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI.

Secondary outcomes

  • BMI [From enrollment to the end of measurement at 12 weeks]: The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Va Greater Los Angeles Healthcare SystemLos Angeles, CaliforniaUnited States

+Investigators