Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
NCT06932289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-04-17
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)
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.
Sponsors & Collaborators
-
VA Greater Los Angeles Healthcare System
lead FED
Principal Investigators
-
Tzung Hsiai, M.D., Ph.D. · VAGLAHS and UCLA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2029-04-30
- Completion
- 2029-05-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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