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

Conditions

• NAFLD (Nonalcoholic Fatty Liver Disease)

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

May 1, 2025

Status verified

Mar 2025

Primary completion

Apr 30, 2029

Completion

May 1, 2029

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• 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.
• 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.
• 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.
• 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.

Primary Outcome Measure

Concentration of glucose [ Time Frame: From enrollment to the end of measurement at 12 weeks ]

Central Contacts

• Tzung Hsiai, M.D., Ph.D.
  310-478-3711
  [email protected]
• Peng Zhao, M.D., Ph.D.
  310-279-0248
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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