MLCT Oil for Fatty Liver - PASS Trial

Non-Alcoholic Fatty Liver Disease Clinical Trial

— PASS  

Official title:

A Randomised Controlled Pilot Study to Test the Role of Medium- and Long-chain Triacylglycerols (MLCT) in Reversing the Phenotype of Non-alcoholic Steatohepatitis (NASH) Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05217745
• Other study ID #: 2019/00618
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2021
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 least a 1-stage reversal between F1 and F4.

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 participants with NASH. The single-centre trial is a 2-arm, randomized pilot study with stratification by BMI. Up to 30 participants with biopsy/imaging proven NAFLD / NASH would undergo blinded 1:1 allocation to either control or test group. All participants would be offered biopsy, whereby a repeat liver biopsy would be undertaken at the end of the study (6 months) to investigate the efficacy of dietary MLCT versus corn oil in augmenting therapy of NASH. Dietary counselling for the participants will be provided by NUH dietician on 6 weekly basis on how to adhere to the required dietary regimen. For the first 12 weeks, participants are to consume only the 3 provided RTE meals (breakfast, lunch and dinner), with additional fruits or low calories snacks to be advised by dietician. During the second 12-week experimental period, participants will follow strict dietary guideline under the recommendation of the NUH dietician and have oil-containing products [chocolate sauce / oatmeal biscuits] with 30 g of corn or MLCT oil per day. During the 6 months, study participants would be followed up at 0, 3, 6, 9, 12, 18 and 24 weeks. During each of the follow up visit, the participant would have blood drawn, urine and stool collected as per study schedule.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-Alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

Intervention

Dietary Supplement:
• MLCT Oil
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil
• LCT Oil (Corn Oil)
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Wilmar International

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Fibrosis	Change in liver fibrosis through liver biopsy or imaging	6 months
Secondary	Body Weight	Change in body weight (kg)	6 months
Secondary	Body fat composition	Change in body fat composition using MRI body profiler (%)	6 months
Secondary	Blood pressure	Change in blood pressure using blood pressure monitor (mmHg)	6 months
Secondary	Body circumferences	Change in waist and hip circumference using measuring tape (cm)	6 months
Secondary	Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)	Change in fasting blood lipid profile (mmol/L)	6 months
Secondary	Fasting Insulin and Glucose	Change in fasting Insulin and Glucose (mmol/L)	6 months
Secondary	Haemoglobin A1c	Change in HBA1c (mmol/mol)	6 months
Secondary	Liver function panel (Albumin, Bilirubin, ALT, AST, ALP, LDH, GGT)	Change in Albumin (g/L), bilirubin (umol/L), ALT, AST, ALP, LDH, GGT (U/L)	6 months
Secondary	Creatinine	Change in serum and urine creatinine (umol/L)	6 months
Secondary	Beta-hydroxybutyrate	Change in beta-hydroxybutyrate (mmol/L)	6 months
Secondary	C-peptide	Change in C-peptide (pmol/L)	6 months
Secondary	Oral glucose tolerance test	Change in glucose level at 120hr timepoint (mmol/L)	6 months
Secondary	C-reactive protein (CRP)	Change in CRP (mg/L)	6 months
Secondary	Inflammatory markers - IL-6, IL-1, TNFalpha	Change in inflammatory markers - IL-6, IL-1, TNFalpha	6 months
Secondary	Gut microflora composition	Change in gut microbiota using gut metagenomics profiling	6 months