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

N/ANot Yet RecruitingNCT06932289

VA Greater Los Angeles Healthcare System54 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Va Greater Los Angeles Healthcare System

Los Angeles, California, United States

Outcomes

Primary Outcomes

Concentration of glucose

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