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Status unknownNCT05217745PASSUpdated Feb 25, 2022

MLCT Oil for Fatty Liver - PASS Trial

An interventional study of MLCT Oil and LCT Oil (Corn Oil) in Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis and NAFLD, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease
  • Non-Alcoholic Steatohepatitis
  • NAFLD
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 451 studies on the registry; 96 are open to participants now.

Browse National University Hospital, Singapore studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment

    MLCT oil (provided through ready to eat meals and snacks)

    Dietary Supplement: MLCT Oil

  • Placebo comparator
    Control

    Corn oil (provided through ready to eat meals and snacks)

    Dietary Supplement: LCT Oil (Corn Oil)

Interventions

  • Dietary supplementMLCT Oil

    1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil

  • Dietary supplementLCT 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

06

What researchers measure

Primary outcomes

  1. Liver Fibrosis

    Change in liver fibrosis through liver biopsy or imaging

    Time frame: 6 months

Secondary outcomes

  1. Body Weight

    Change in body weight (kg)

    Time frame: 6 months

  2. Body fat composition

    Change in body fat composition using MRI body profiler (%)

    Time frame: 6 months

  3. Blood pressure

    Change in blood pressure using blood pressure monitor (mmHg)

    Time frame: 6 months

  4. Body circumferences

    Change in waist and hip circumference using measuring tape (cm)

    Time frame: 6 months

  5. Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)

    Change in fasting blood lipid profile (mmol/L)

    Time frame: 6 months

  6. Fasting Insulin and Glucose

    Change in fasting Insulin and Glucose (mmol/L)

    Time frame: 6 months

  7. Haemoglobin A1c

    Change in HBA1c (mmol/mol)

    Time frame: 6 months

  8. 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)

    Time frame: 6 months

  9. Creatinine

    Change in serum and urine creatinine (umol/L)

    Time frame: 6 months

  10. Beta-hydroxybutyrate

    Change in beta-hydroxybutyrate (mmol/L)

    Time frame: 6 months

  11. C-peptide

    Change in C-peptide (pmol/L)

    Time frame: 6 months

  12. Oral glucose tolerance test

    Change in glucose level at 120hr timepoint (mmol/L)

    Time frame: 6 months

  13. C-reactive protein (CRP)

    Change in CRP (mg/L)

    Time frame: 6 months

  14. Inflammatory markers - IL-6, IL-1, TNFalpha

    Change in inflammatory markers - IL-6, IL-1, TNFalpha

    Time frame: 6 months

  15. Gut microflora composition

    Change in gut microbiota using gut metagenomics profiling

    Time frame: 6 months

07

Study locations

1 site
  • National University Hospital
    Singapore, 119074, Singapore
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05217745
Lead sponsor
National University Hospital, Singapore
Collaborators
Wilmar International
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Aug 5, 2021
Primary completion
Mar 31, 2022 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Feb 25, 2022

Study contacts

Dan Yock Young
principal investigator · National University Hospital, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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