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

NCT06932289 | Not Yet Recruiting FDA Device

• 1 other identifier: 1832799-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)

Keywords

NAFLD; metabolic responses; mixed meal challenge

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• BMI

  From enrollment to the end of measurement at 12 weeks

Study Arms (4)

Diet 1 (one of the three kinds of diets)

ACTIVE COMPARATOR

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); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM)

Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)

ACTIVE COMPARATOR

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); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM)

Diet 3 (the final remaining diet)

ACTIVE COMPARATOR

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); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM)

Habitual diet as a baseline

EXPERIMENTAL

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); Device: continuous glucose monitor (CGM)

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).

Diet 1 (one of the three kinds of diets); Diet 2 (one of the two remaining kinds of diets, excluding Diet 1); Diet 3 (the final remaining diet)

The integrated sweat sensor and vascular sensor (wearable) DEVICE

The integrated sweat sensor and vascular sensor will be worn of each diet period.

Diet 1 (one of the three kinds of diets); Diet 2 (one of the two remaining kinds of diets, excluding Diet 1); Diet 3 (the final remaining diet); Habitual diet as a baseline

continuous glucose monitor (CGM) DEVICE

A continuous glucose monitor (CGM) will be placed on the patients during each diet period.

Diet 1 (one of the three kinds of diets); Diet 2 (one of the two remaining kinds of diets, excluding Diet 1); Diet 3 (the final remaining diet); Habitual diet as a baseline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

Va Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Mediterranean; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Tzung Hsiai, M.D., Ph.D.

  VAGLAHS and UCLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzung Hsiai, M.D., Ph.D.

CONTACT

310-478-3711; thsiai@mednet.ucla.edu

Peng Zhao, M.D., Ph.D.

CONTACT

310-279-0248; pengzhao@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: April 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)