A Feasibility Trial of OCM Supplements for the Treatment of NAFLD
NCT ID: NCT05720702
Last Updated: 2024-11-27
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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COMPLETED
EARLY_PHASE1
31 participants
INTERVENTIONAL
2023-06-30
2024-08-23
Brief Summary
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NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits to complete activities such as physical exam, fibroscan, blood draws, and questionnaires.
Detailed Description
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NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits. During the in person visits NAFLD participants will complete the following activities:
* Review medical history
* Physical examination
* Vital signs (blood pressure, heart rate, respiratory rate, body temperature)
* Measure height, weight, body mass index, and waist circumference
* Grip test
* Fasting blood tests
* Pregnancy test (if applicable)
* Fibroscan with CAP score
* QOL questionnaire
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NAFLD Group
The NAFLD group will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits. During the in person visits NAFLD participants will complete the following activities:
Review medical history; Physical examination; Vital signs (blood pressure, heart rate, respiratory rate, body temperature); Measure height, weight, body mass index, and waist circumference; Grip test; Fasting blood tests; Pregnancy test (if applicable); Fibroscan with CAP score; QOL questionnaire
homocysteine (Hcy) lowering supplements
NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks.
Interventions
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homocysteine (Hcy) lowering supplements
NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
2. HOMA-IR ≥ 2 or the diagnosis of metabolic syndrome
3. Chronic elevation of transaminases: ALT elevation (more than 2 times during the past 12 months, defined by 19 U/L for women and 30 U/L for men 31)
4. Stable use of any potential anti-NASH therapy (i.e., vitamin E, pioglitazone, glucagon like peptide 1 agonist, etc.) for 6 months prior to screening.
5. Aged 18+ years
6. Able to provide legal consent
Exclusion Criteria
2. Inability to obtain valid fibroscan measures at the screening
3. Pregnancy or lactation
4. Clinical diagnosis of cirrhosis or other chronic liver diseases
5. Recent use of steatogenic medications
6. Excess alcohol use (\>21/ \>14 drinks weekly in men/women)
7. Chronic kidney disease
8. Supplement use within 30 days, containing any of the study supplements
9. Total parenteral nutrition
10. Any clinical conditions associated with malabsorption
11. Any active diagnosis of malignancy
12. Use of immunosuppression
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Ayako Suzuki
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00112107
Identifier Type: -
Identifier Source: org_study_id