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Monitoring Cardiometabolic Disorders After Nutrition Interventions

This 12-week study is looking at how different diets affect your body's metabolism and blood vessel health, especially if you have Nonalcoholic Fatty Liver Disease (NAFLD). Researchers want to see how Mediterranean, high-fat/low-carb, and low-fat diets impact your glucose (blood sugar), cholesterol, and triglycerides (a type of fat in your blood). You would wear special sensors that measure things in your sweat and blood vessels, along with a continuous glucose monitor (CGM). To join, you need to be a US Veteran between 18 and 55 years old and have at least two signs of metabolic syndrome, such as a certain waist size or high blood pressure. The study is planned for 54 participants, but its current recruitment status is unclear.

Study design
This is a randomized, controlled crossover study involving 54 participants. You will try three different diets with breaks in between.
What's involved
You will follow three different diets for 14 days each, with 2-week breaks between diets. During each diet period, you will wear a sweat sensor, a vascular sensor, and a continuous glucose monitor, and blood samples will be collected.
Compensation
Not stated in the trial record.
Follow-up
Your glucose, cholesterol, and triglyceride levels will be measured from enrollment until the end of the study at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06932289

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

Not Yet Recruiting
NAAges 18–55InterventionalBasic science
VA Greater Los Angeles Healthcare System
~54 participants
Updated 2025-04-17 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of glucose
Measured over From enrollment to the end of measurement at 12 weeks
+8 more outcomes measured

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)

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NCT06932289

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Va Greater Los Angeles Healthcare System

    Los Angeles, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tzung Hsiai, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · VAGLAHS and UCLA

Who to contact

Tzung Hsiai, M.D., Ph.D.
[email protected]
310-478-3711
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Concentration of glucoseFrom 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 cholesterolFrom 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 weightFrom 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.

  • HeightFrom 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.