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Non-Alcoholic Fatty Liver DiseasePASSNCT05217745

MLCT Oil for Fatty Liver - PASS Trial

A study testing MLCT Oil and LCT Oil (Corn Oil) in people with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
MLCT Oil and LCT Oil (Corn Oil)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSingapore
Study dates
5 Aug 2021to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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

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.

Being tested
MLCT Oil, LCT Oil (Corn Oil)
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MLCT OilDietary supplement

    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)Dietary supplement

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

Study groups in NCT05217745
Study groupRoleWhat they receive
TreatmentExperimentalMLCT oil (provided through ready to eat meals and snacks)
Receives: Dietary Supplement: MLCT Oil
ControlPlacebo comparatorCorn oil (provided through ready to eat meals and snacks)
Receives: Dietary Supplement: LCT Oil (Corn Oil)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver Fibrosis

    Change in liver fibrosis through liver biopsy or imaging

    Measured: 6 months

Secondary outcomes (15)

  1. Body Weight

    Change in body weight (kg)

    Measured: 6 months

  2. Body fat composition

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

    Measured: 6 months

  3. Blood pressure

    Change in blood pressure using blood pressure monitor (mmHg)

    Measured: 6 months

  4. Body circumferences

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

    Measured: 6 months

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

    Change in fasting blood lipid profile (mmol/L)

    Measured: 6 months

  6. Fasting Insulin and Glucose

    Change in fasting Insulin and Glucose (mmol/L)

    Measured: 6 months

  7. Haemoglobin A1c

    Change in HBA1c (mmol/mol)

    Measured: 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)

    Measured: 6 months

  9. Creatinine

    Change in serum and urine creatinine (umol/L)

    Measured: 6 months

  10. Beta-hydroxybutyrate

    Change in beta-hydroxybutyrate (mmol/L)

    Measured: 6 months

  11. C-peptide

    Change in C-peptide (pmol/L)

    Measured: 6 months

  12. Oral glucose tolerance test

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

    Measured: 6 months

  13. C-reactive protein (CRP)

    Change in CRP (mg/L)

    Measured: 6 months

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

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

    Measured: 6 months

  15. Gut microflora composition

    Change in gut microbiota using gut metagenomics profiling

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start5 Aug 2021
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05217745
Sponsor's protocol ID
2019/00618
Other IDs
2019
Acronym
PASS
Status last verified
Sep 2021
First submitted
9 Sep 2021
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MLCT Oil and LCT Oil (Corn Oil) in people with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver Fibrosis (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.

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