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MLCT Oil for Fatty Liver - PASS Trial (PASS)

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, NAFLD

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
MLCT Oil
LCT Oil (Corn Oil)
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Liver Fibrosis
Change in liver fibrosis through liver biopsy or imaging

Secondary Outcome Measures

Body Weight
Change in body weight (kg)
Body fat composition
Change in body fat composition using MRI body profiler (%)
Blood pressure
Change in blood pressure using blood pressure monitor (mmHg)
Body circumferences
Change in waist and hip circumference using measuring tape (cm)
Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)
Change in fasting blood lipid profile (mmol/L)
Fasting Insulin and Glucose
Change in fasting Insulin and Glucose (mmol/L)
Haemoglobin A1c
Change in HBA1c (mmol/mol)
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)
Creatinine
Change in serum and urine creatinine (umol/L)
Beta-hydroxybutyrate
Change in beta-hydroxybutyrate (mmol/L)
C-peptide
Change in C-peptide (pmol/L)
Oral glucose tolerance test
Change in glucose level at 120hr timepoint (mmol/L)
C-reactive protein (CRP)
Change in CRP (mg/L)
Inflammatory markers - IL-6, IL-1, TNFalpha
Change in inflammatory markers - IL-6, IL-1, TNFalpha
Gut microflora composition
Change in gut microbiota using gut metagenomics profiling

Full Information

First Posted
September 9, 2021
Last Updated
February 8, 2022
Sponsor
National University Hospital, Singapore
Collaborators
Wilmar International
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1. Study Identification

Unique Protocol Identification Number
NCT05217745
Brief Title
MLCT Oil for Fatty Liver - PASS Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Wilmar International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
MLCT oil (provided through ready to eat meals and snacks)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Corn oil (provided through ready to eat meals and snacks)
Intervention Type
Dietary Supplement
Intervention Name(s)
MLCT Oil
Intervention Description
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil
Intervention Type
Dietary Supplement
Intervention Name(s)
LCT Oil (Corn Oil)
Intervention Description
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil
Primary Outcome Measure Information:
Title
Liver Fibrosis
Description
Change in liver fibrosis through liver biopsy or imaging
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body Weight
Description
Change in body weight (kg)
Time Frame
6 months
Title
Body fat composition
Description
Change in body fat composition using MRI body profiler (%)
Time Frame
6 months
Title
Blood pressure
Description
Change in blood pressure using blood pressure monitor (mmHg)
Time Frame
6 months
Title
Body circumferences
Description
Change in waist and hip circumference using measuring tape (cm)
Time Frame
6 months
Title
Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)
Description
Change in fasting blood lipid profile (mmol/L)
Time Frame
6 months
Title
Fasting Insulin and Glucose
Description
Change in fasting Insulin and Glucose (mmol/L)
Time Frame
6 months
Title
Haemoglobin A1c
Description
Change in HBA1c (mmol/mol)
Time Frame
6 months
Title
Liver function panel (Albumin, Bilirubin, ALT, AST, ALP, LDH, GGT)
Description
Change in Albumin (g/L), bilirubin (umol/L), ALT, AST, ALP, LDH, GGT (U/L)
Time Frame
6 months
Title
Creatinine
Description
Change in serum and urine creatinine (umol/L)
Time Frame
6 months
Title
Beta-hydroxybutyrate
Description
Change in beta-hydroxybutyrate (mmol/L)
Time Frame
6 months
Title
C-peptide
Description
Change in C-peptide (pmol/L)
Time Frame
6 months
Title
Oral glucose tolerance test
Description
Change in glucose level at 120hr timepoint (mmol/L)
Time Frame
6 months
Title
C-reactive protein (CRP)
Description
Change in CRP (mg/L)
Time Frame
6 months
Title
Inflammatory markers - IL-6, IL-1, TNFalpha
Description
Change in inflammatory markers - IL-6, IL-1, TNFalpha
Time Frame
6 months
Title
Gut microflora composition
Description
Change in gut microbiota using gut metagenomics profiling
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Yock Young
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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MLCT Oil for Fatty Liver - PASS Trial

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