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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil
1st 12 weeks: frozen ready to eat meals prepared with the oil Last 12 weeks: own diet with provided snacks containing the oil
National University Hospital
Singapore, Singapore
Liver Fibrosis
Change in liver fibrosis through liver biopsy or imaging
Time frame: 6 months
Body Weight
Change in body weight (kg)
Time frame: 6 months
Body fat composition
Change in body fat composition using MRI body profiler (%)
Time frame: 6 months
Blood pressure
Change in blood pressure using blood pressure monitor (mmHg)
Time frame: 6 months
Body circumferences
Change in waist and hip circumference using measuring tape (cm)
Time frame: 6 months
Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides)
Change in fasting blood lipid profile (mmol/L)
Time frame: 6 months
Fasting Insulin and Glucose
Change in fasting Insulin and Glucose (mmol/L)
Time frame: 6 months
Haemoglobin A1c
Change in HBA1c (mmol/mol)
Time frame: 6 months
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)
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Time frame: 6 months
Creatinine
Change in serum and urine creatinine (umol/L)
Time frame: 6 months
Beta-hydroxybutyrate
Change in beta-hydroxybutyrate (mmol/L)
Time frame: 6 months
C-peptide
Change in C-peptide (pmol/L)
Time frame: 6 months
Oral glucose tolerance test
Change in glucose level at 120hr timepoint (mmol/L)
Time frame: 6 months
C-reactive protein (CRP)
Change in CRP (mg/L)
Time frame: 6 months
Inflammatory markers - IL-6, IL-1, TNFalpha
Change in inflammatory markers - IL-6, IL-1, TNFalpha
Time frame: 6 months
Gut microflora composition
Change in gut microbiota using gut metagenomics profiling
Time frame: 6 months