- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646197
Effects of Peanut Consumption on Adults With Metabolic Associated Fatty Liver Disease
Impacts of Peanut Intake on Hepatic Markers and Gut Microbiota in Adults With MASLD
The aim of this randomized interventional trial is to understand the effects of peanut consumption on patients with metabolic associated fatty liver. The main goal is to investigate if patients who consume peanuts have improved liver marker tests as well as metabolic profile. We will also investigate how peanuts alter the gut microbes and liver fat content in patients with metabolic associated fatty liver.
- Participants will be randomized into intervention (peanut consumption for 12 weeks) and control (regular diet) arm.
- Stool sample and blood (for biomarkers) collection across both arms at baseline and post-intervention
- Daily log to be completed for tracking peanut consumption
- 2-day Dietary recall at baseline, during Week 6 and Week 12
- Poat intervention Fibro scans for participants with baseline scans available
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Menghua Tao, PhD
- Phone Number: 313-590-9408
- Email: mtao1@hfhs.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
-
Contact:
- Menghua Tao, Ph.D.
- Phone Number: 3138768471
- Email: mtao1@hfhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 30-70 years
- do not consume peanut/peanut butter/treenut/seeds > /week
- at least one encounter-related (stage F0/F1) MASLD diagnosis (K76.0)
- Able to understand, speak, and read English
- Mentally competent to consent
Exclusion Criteria:
- Food allergy to peanuts or peanut-containing products
- With alcohol use disorder (AUDIT screening)
- Leukemia
- Lymphoma
- Other types of cancer
- Heart or cardiovascular diseases (such as heart attack, stroke, heart failure)
- Kidney diseases (such as chronic kidney disease, kidney transplant, renal insufficiency such as renal failure requiring dialysis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peanut
MASLD patients will consume 50 gm of peanut daily for 12 weeks
|
MASLD patients will consume 50 gm of peanut daily for 12 weeks
|
|
No Intervention: Control
Regular diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hepatic Markers
Time Frame: Baseline to post-intervention (12 weeks)
|
Changes in hepatic markers such as ALT, ASP, ALP will be evaluated through blood tests at baseline and post-intervention
|
Baseline to post-intervention (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic Profile
Time Frame: Baseline to post-intervention (12 weeks)
|
Investigate change in metabolic profiles i.e., total cholesterol, HDL-C, LDL-C, triglycerides, glucose, hemoglobin A1C (HBA1C), and insulin over 12 weeks
|
Baseline to post-intervention (12 weeks)
|
|
Gut microbiota composition
Time Frame: Baseline to post-intervention (12 weeks)
|
Investigate whether MASLD patients in the Peanut arm will have improved gut microbiota compositions than those in the Control arm
|
Baseline to post-intervention (12 weeks)
|
|
Intrahepatic fat content
Time Frame: Baseline to post-intervention (12 weeks)
|
Explore whether MASLD patients in the Peanut arm may have lower intrahepatic fat content (IHF) than those in the Control arm over 12 weeks
|
Baseline to post-intervention (12 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19113
- F20581 (Other Grant/Funding Number: The Peanut Institute Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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