Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
NCT ID: NCT06932289
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2025-05-01
2029-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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.
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).
The integrated sweat sensor and vascular sensor (wearable)
The integrated sweat sensor and vascular sensor will be worn of each diet period.
continuous glucose monitor (CGM)
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
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.
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).
The integrated sweat sensor and vascular sensor (wearable)
The integrated sweat sensor and vascular sensor will be worn of each diet period.
continuous glucose monitor (CGM)
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
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.
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).
The integrated sweat sensor and vascular sensor (wearable)
The integrated sweat sensor and vascular sensor will be worn of each diet period.
continuous glucose monitor (CGM)
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
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.
The integrated sweat sensor and vascular sensor (wearable)
The integrated sweat sensor and vascular sensor will be worn of each diet period.
continuous glucose monitor (CGM)
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
Interventions
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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).
The integrated sweat sensor and vascular sensor (wearable)
The integrated sweat sensor and vascular sensor will be worn of each diet period.
continuous glucose monitor (CGM)
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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VA Greater Los Angeles Healthcare System
FED
Responsible Party
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Principal Investigators
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Tzung Hsiai, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VAGLAHS and UCLA
Locations
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Va Greater Los Angeles Healthcare System
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1832799-1
Identifier Type: -
Identifier Source: org_study_id
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