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NCT Number: NCT06932289

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Concentration of glucose

    Time frame: 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

  2. Concentration of cholesterol

    Time frame: 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.

  3. Concentration of triacylglycerol (TG)

    Time frame: 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.

  4. Concentration of Nitric oxide (NO)

    Time frame: 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.

  5. Measurement of heart rate (HR)

    Time frame: 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.

  6. Measurement of heart rate variability (HRV)

    Time frame: 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.

  7. Measurement of pulse wave velocity (PWV)

    Time frame: 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.

  8. Body weight

    Time frame: 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.

  9. Height

    Time frame: 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

  1. BMI

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Zhao, M.D., Ph.D.

CONTACT

[email protected]

310-279-0248

Tzung Hsiai, M.D., Ph.D.

CONTACT

[email protected]

310-478-3711

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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