Va Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Location contact
Peng Zhao
CONTACT
Tzung Hsiai, M.D., Ph.D.
CONTACT
NCT Number: NCT06932289
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90073, United States
Peng Zhao
CONTACT
Tzung Hsiai, M.D., Ph.D.
CONTACT
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 first phase, all participants will consume their habitual diet for 2 weeks to establish baseline. Then participants will be randomized to either a Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF) for 14 days with 2 weeks washout between the different diets. The wearable system will monitor basal levels and the changes for glucose, cholesterol, TG, and NO through sweat analysis and HR, HRV, and PWV for carotid arterial stiffness during each diet intervention.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 will be worn of each diet period.
A continuous glucose monitor (CGM) will be placed on the patients during each diet period.
Time frame: From enrollment to the end of measurement at 12 weeks
The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism
Time frame: From enrollment to the end of measurement at 12 weeks
The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Time frame: From enrollment to the end of measurement at 12 weeks]
The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Time frame: From enrollment to the end of measurement at 12 weeks
The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Time frame: From enrollment to the end of measurement at 12 weeks
The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Time frame: From enrollment to the end of measurement at 12 weeks
The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Time frame: From enrollment to the end of measurement at 12 weeks
The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness.
Time frame: From enrollment to the end of measurement at 12 weeks
The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI.
Time frame: From enrollment to the end of measurement at 12 weeks
The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI.
Time frame: From enrollment to the end of measurement at 12 weeks
The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat.
Contact information is provided by the study sponsor or research team.
Peng Zhao, M.D., Ph.D.
CONTACT
Tzung Hsiai, M.D., Ph.D.
CONTACT
VA Greater Los Angeles Healthcare System
Fed
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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