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.

Study Overview

• Status: Not yet recruiting
• Conditions: NAFLD (Nonalcoholic Fatty Liver Disease)
• Intervention / Treatment: Dietary supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzung Hsiai, M.D., Ph.D.; Phone Number: 310-478-3711; Email: thsiai@mednet.ucla.edu
• Study Contact Backup: Name: Peng Zhao, M.D., Ph.D.; Phone Number: 310-279-0248; Email: pengzhao@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
      • Contact: Tzung Hsiai, M.D., Ph.D.; Phone Number: 310-825-9029; Email: thsiai@mednet.ucla.edu
      • Contact: Peng Zhao; Phone Number: 310-279-0248; Email: pengzhao@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet 1 (one of the three kinds of diets); participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.	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.
Active Comparator: Diet 2 (one of the two remaining kinds of diets, excluding Diet 1); participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.	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.
Active Comparator: Diet 3 (the final remaining diet); participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.	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.
Experimental: Habitual diet as a baseline; All participants will consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of glucose	The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism	From enrollment to the end of measurement at 12 weeks
Concentration of cholesterol	The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.	From enrollment to the end of measurement at 12 weeks
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.	From enrollment to the end of measurement at 12 weeks]
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.	From enrollment to the end of measurement at 12 weeks
Measurement of heart rate (HR)	The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.	From enrollment to the end of measurement at 12 weeks
Measurement of heart rate variability (HRV)	The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.	From enrollment to the end of measurement at 12 weeks
Measurement of pulse wave velocity (PWV)	The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness.	From enrollment to the end of measurement at 12 weeks
Body weight	The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI.	From enrollment to the end of measurement at 12 weeks
Height	The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI.	From enrollment to the end of measurement at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat.	From enrollment to the end of measurement at 12 weeks

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Investigators: Principal Investigator: Tzung Hsiai, M.D., Ph.D., VAGLAHS and UCLA

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: NAFLD; metabolic responses; mixed meal challenge
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 1832799-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The results of a research study may be published in the medical literature or presented at scientific medical or educational meetings, but the Veteran participant's name or identity will not be revealed, and their records will remain confidential unless disclosure of your identity is required by law.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes