Status:
NOT_YET_RECRUITING
Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Conditions:
NAFLD (Nonalcoholic Fatty Liver Disease)
Eligibility:
All Genders
18-55 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06932289
Start Date
May 1 2025
End Date
May 1 2029
Last Update
April 17 2025
Active Locations (1)
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1
Va Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073