Fatty Liver, MASLD
Conditions
Keywords
fatty liver, masld, peanut, hepatic, intervention, gut microbe
Brief summary
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
Interventions
OTHERPeanut consumption
MASLD patients will consume 50 gm of peanut daily for 12 weeks
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic Markers | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Profile | 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 |
| Gut microbiota composition | 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 |
| Intrahepatic fat content | 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 |
Countries
United States
Contacts
CONTACTMenghua Tao, PhD
Outcome results
None listed