NAFLD (Nonalcoholic Fatty Liver Disease)NCT06932289
Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
A study testing Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), The integrated sweat sensor and vascular sensor (wearable) and continuous glucose monitor (CGM) in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), The integrated sweat sensor and vascular sensor (wearable) and continuous glucose monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Va Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Tzung Hsiai, M.D., Ph.D., 310-825-9029, thsiai@mednet.ucla.edu
Peng Zhao, 310-279-0248, pengzhao@mednet.ucla.edu
About this study
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.
Read the 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 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.
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Being tested
- Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), The integrated sweat sensor and vascular sensor (wearable), continuous glucose monitor (CGM)
- Keywords
- NAFLD, metabolic responses, mixed meal challenge
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Diet 1 (one of the three kinds of diets) | Active comparator | 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. Receives: Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM) |
| Diet 2 (one of the two remaining kinds of diets, excluding Diet 1) | Active comparator | 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. Receives: Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM) |
| Diet 3 (the final remaining diet) | Active comparator | 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. Receives: Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF); Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM) |
| Habitual diet as a baseline | Experimental | 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. Receives: Device: The integrated sweat sensor and vascular sensor (wearable); Device: continuous glucose monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of glucose
The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism
Measured: From enrollment to the end of measurement at 12 weeks
Concentration of cholesterol
The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Measured: From enrollment to the end of measurement at 12 weeks
Concentration of triacylglycerol (TG)
The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Measured: From enrollment to the end of measurement at 12 weeks]
Concentration of Nitric oxide (NO)
The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Measured: From enrollment to the end of measurement at 12 weeks
Measurement of heart rate (HR)
The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Measured: From enrollment to the end of measurement at 12 weeks
Measurement of heart rate variability (HRV)
The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Measured: From enrollment to the end of measurement at 12 weeks
Measurement of pulse wave velocity (PWV)
The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness.
Measured: From enrollment to the end of measurement at 12 weeks
Body weight
The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI.
Measured: From enrollment to the end of measurement at 12 weeks
Height
The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI.
Measured: From enrollment to the end of measurement at 12 weeks
Secondary outcomes (1)
BMI
The Body mass index (BMI) (kg/m2) will be measured during each visit, across the different diets, to evaluate changes of body fat.
Measured: From enrollment to the end of measurement at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD (Nonalcoholic Fatty Liver Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tzung Hsiai, M.D., Ph.D., Principal investigator, VAGLAHS and UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932289
- Sponsor's protocol ID
- 1832799-1
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The results of a research study may be published in the medical literature or presented at scientific medical or educational meetings, but the Veteran participant's name or identity will not be revealed, and their records will remain confidential unless disclosure of your identity is required by law.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
- ClinicalTrials.gov ID
- NCT06932289
- Acronym / sponsor ID
- 1832799-1
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Keywords
- NAFLD, metabolic responses, mixed meal challenge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet 1 (one of the three kinds of diets) | Active comparator | Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), Device: The integrated sweat sensor and vascular sensor (wearable), Device: continuous glucose monitor (CGM)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. |
| Diet 2 (one of the two remaining kinds of diets, excluding Diet 1) | Active comparator | Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), Device: The integrated sweat sensor and vascular sensor (wearable), Device: continuous glucose monitor (CGM)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. |
| Diet 3 (the final remaining diet) | Active comparator | Dietary Supplement: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), Device: The integrated sweat sensor and vascular sensor (wearable), Device: continuous glucose monitor (CGM)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. |
| Habitual diet as a baseline | Experimental | Device: The integrated sweat sensor and vascular sensor (wearable), Device: continuous glucose monitor (CGM)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | Diet 1 (one of the three kinds of diets), Diet 2 (one of the two remaining kinds of diets, excluding Diet 1), Diet 3 (the final remaining diet) |
| The integrated sweat sensor and vascular sensor (wearable)The integrated sweat sensor and vascular sensor will be worn of each diet period. | Device | Diet 1 (one of the three kinds of diets), Diet 2 (one of the two remaining kinds of diets, excluding Diet 1), Diet 3 (the final remaining diet), Habitual diet as a baseline |
| continuous glucose monitor (CGM)A continuous glucose monitor (CGM) will be placed on the patients during each diet period. | Device | Diet 1 (one of the three kinds of diets), Diet 2 (one of the two remaining kinds of diets, excluding Diet 1), Diet 3 (the final remaining diet), Habitual diet as a baseline |
Primary outcome
Concentration of glucose
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
Concentration of cholesterol
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.
Concentration of triacylglycerol (TG)
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.
Concentration of Nitric oxide (NO)
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.
Measurement of heart rate (HR)
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.
Measurement of heart rate variability (HRV)
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.
Measurement of pulse wave velocity (PWV)
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.
Body weight
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.
Height
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.
1 secondary outcome
BMI
Time frame: From enrollment to the end of measurement at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. The results of a research study may be published in the medical literature or presented at scientific medical or educational meetings, but the Veteran participant's name or identity will not be revealed, and their records will remain confidential unless disclosure of your identity is required by law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tzung Hsiai, M.D., Ph.D. principal investigator
VAGLAHS and UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF), The integrated sweat sensor and vascular sensor (wearable) and continuous glucose monitor (CGM) in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tzung Hsiai, M.D., Ph.D. (310-478-3711, thsiai@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of glucose (time frame: From enrollment to the end of measurement at 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.