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| Name | Class |
|---|---|
| Wilmar International | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | MLCT oil (provided through ready to eat meals and snacks) |
|
| Control | Placebo Comparator | Corn oil (provided through ready to eat meals and snacks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLCT 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Fibrosis | Change in liver fibrosis through liver biopsy or imaging | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change in body weight (kg) | 6 months |
| Body fat composition | Change in body fat composition using MRI body profiler (%) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Yock Young | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| 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 |
|
| Blood pressure | Change in blood pressure using blood pressure monitor (mmHg) | 6 months |
| Body circumferences | Change in waist and hip circumference using measuring tape (cm) | 6 months |
| Blood lipid profile (HDL, LDL, Total cholesterol, Triglycerides) | Change in fasting blood lipid profile (mmol/L) | 6 months |
| Fasting Insulin and Glucose | Change in fasting Insulin and Glucose (mmol/L) | 6 months |
| Haemoglobin A1c | Change in HBA1c (mmol/mol) | 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) | 6 months |
| Creatinine | Change in serum and urine creatinine (umol/L) | 6 months |
| Beta-hydroxybutyrate | Change in beta-hydroxybutyrate (mmol/L) | 6 months |
| C-peptide | Change in C-peptide (pmol/L) | 6 months |
| Oral glucose tolerance test | Change in glucose level at 120hr timepoint (mmol/L) | 6 months |
| C-reactive protein (CRP) | Change in CRP (mg/L) | 6 months |
| Inflammatory markers - IL-6, IL-1, TNFalpha | Change in inflammatory markers - IL-6, IL-1, TNFalpha | 6 months |
| Gut microflora composition | Change in gut microbiota using gut metagenomics profiling | 6 months |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |