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Not yet recruiting NCT06932289

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

No phase Interventional NAFLD (Nonalcoholic Fatty Liver Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: NAFLD (Nonalcoholic Fatty Liver Disease). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Concentration of glucose [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Concentration of cholesterol [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Concentration of triacylglycerol (TG) [Time frame: From enrollment to the end of measurement at 12 weeks]]
  • Concentration of Nitric oxide (NO) [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Measurement of heart rate (HR) [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Measurement of heart rate variability (HRV) [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Measurement of pulse wave velocity (PWV) [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Body weight [Time frame: From enrollment to the end of measurement at 12 weeks]
  • Height [Time frame: From enrollment to the end of measurement at 12 weeks]
Secondary outcome measures (1)
  • BMI [Time frame: From enrollment to the end of measurement at 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Va Greater Los Angeles Healthcare System — Los Angeles

Identifiers

NCT: NCT06932289 · 1832799-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗