NCT05217745

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

February 25, 2022

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

September 9, 2021

Last Update Submit

February 8, 2022

Conditions

Non-Alcoholic Fatty Liver DiseaseNon-Alcoholic SteatohepatitisNAFLD

Outcome Measures

Primary Outcomes (1)

  • Liver Fibrosis

    Change in liver fibrosis through liver biopsy or imaging

    6 months

Secondary Outcomes (15)

  • Body Weight

    6 months

  • Body fat composition

    6 months

  • Blood pressure

    6 months

  • Body circumferences

    6 months

  • Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)

    6 months

  • +10 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: MLCT Oil

Control

PLACEBO COMPARATOR

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

Dietary Supplement: LCT Oil (Corn Oil)

Interventions

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

Treatment
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

Control

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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);
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dan Yock Young

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

February 1, 2022

Study Start

August 5, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2023

Last Updated

February 25, 2022

Record last verified: 2021-09

Locations

SG(1)