Effects of Peanut Consumption on Adults With Metabolic Associated Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorHenry Ford Health System
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Food allergy to peanuts or peanut-containing products
With alcohol use disorder (AUDIT screening)
Leukemia
Lymphoma
Trial design
Design model
Parallel
Treatments tested in this trial
Peanut consumption
Other interventionMASLD patients will consume 50 gm of peanut daily for 12 weeks
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: PeanutExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hepatic Markers
Changes in hepatic markers such as ALT, ASP, ALP will be evaluated through blood tests at baseline and post-intervention
Time frame
Baseline to post-intervention (12 weeks)Secondary outcomes
1
Metabolic Profile
Investigate change in metabolic profiles i.e., total cholesterol, HDL-C, LDL-C, triglycerides, glucose, hemoglobin A1C (HBA1C), and insulin over 12 weeks
Time frame
Baseline to post-intervention (12 weeks)2
Gut microbiota composition
Investigate whether MASLD patients in the Peanut arm will have improved gut microbiota compositions than those in the Control arm
Time frame
Baseline to post-intervention (12 weeks)3
Intrahepatic fat content
Explore whether MASLD patients in the Peanut arm may have lower intrahepatic fat content (IHF) than those in the Control arm over 12 weeks
Time frame
Baseline to post-intervention (12 weeks)Sponsors and contacts
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Source ClinicalTrials.gov