Status:
UNKNOWN
MLCT Oil for Fatty Liver - PASS Trial
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Wilmar International
Conditions:
Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Steatohepatitis
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The main objective of this randomised pilot study is to explore the relative efficacy of dietary MLCT oil versus LCT oil (corn oil) in augmenting therapy of overweight and obese NAFLD patients with at...
Detailed Description
The hypothesis of the study will be that daily intake of MLCT oil is more effective than corn oil in improving either NAFLD or NASH phenotype, with a greater reduction in liver fibrosis stage of parti...
Eligibility Criteria
Inclusion
- Between 21 to 65 years old;
- Body mass index (BMI) 23 kg/m2 or higher;
- NAFLD or NASH as determined by liver biopsies within last 2 years with fibrosis stage F1-F4; OR Presence of steatosis and fibrosis via Transient Elastography / MRI
- Participants willing and able to adhere to the prohibitions and restrictions specified in the protocol;
- Participants willing and able to adhere to the dietary prescription as in the study protocol;
- Participants willing and able to provide written informed consent.
- Participants able to read and write English, and own a smartphone with a data plan
Exclusion
- Poorly controlled diabetes
- Poorly controlled hypertension
- Estimated glomerular filtration rate of less than 60 ml/min/1.73m2;
- Presence of active alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis; autoimmune hepatitis, and liver cancer;
- A history of Type 1 diabetes mellitus or previous admission for diabetic ketoacidosis;
- Recurrent urinary tract infection (2 or more over the past one year);
- Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known active hyperthyroidism or hypothyroidism);
- Serious medical disease with likely life expectancy less than 5 years;
- Recently started on selected diabetes / hypertensive medications. Must be on stable doses.
- Ongoing eating disorder or significant weight loss or weight gain as defined by change of 5% or more within 12 weeks before screening visit;
- History of any malignancy within 5 years of screening;
- Women who are pregnant or plan to become pregnant;
- Taking alcohol above the limit recommended (i.e. consumed more than 10 g/day for women or 20 g/day for men);
- Participation in other clinical trial in the 30 days before randomization;
- Participants who cannot be followed up for at least 6 weeks (due to health situation or travel);
- Having allergies / intolerances to the ingredients in the prepared meals or oil-containing products of the study;
- Having chronic gastrointestinal disorders;
- Having taken antibiotics in the last 3 months;
- Participants with arthropathy, CVM, CVA disorder or any systemic disorder which render or when intervention may be dangerous.
Key Trial Info
Start Date :
August 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05217745
Start Date
August 5 2021
End Date
March 31 2023
Last Update
February 25 2022
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074