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

ConditionNAFLD (Nonalcoholic Fatty Liver Disease)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVA Greater Los Angeles Healthcare System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

54 Participants
are divided into 4 treatment groups
Group A: Diet 1 (one of the three kinds of diets)Active comparator 3 interventions
Group B: Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)Active comparator 3 interventions
Group C: Diet 3 (the final remaining diet)Active comparator 3 interventions
Group D: Habitual diet as a baselineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Concentration of glucose

The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism

Time frame
From enrollment to the end of measurement at 12 weeks
2

Concentration of cholesterol

The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.

Time frame
From enrollment to the end of measurement at 12 weeks
3

Concentration of triacylglycerol (TG)

The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.

Time frame
From enrollment to the end of measurement at 12 weeks]
4

Concentration of Nitric oxide (NO)

The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism.

Time frame
From enrollment to the end of measurement at 12 weeks

Secondary outcomes

1

BMI

The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat.

Time frame
From enrollment to the end of measurement at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Greater Los Angeles Healthcare System

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: