Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000757516
Ethics application status
Approved
Date submitted
25/06/2015
Date registered
21/07/2015
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of canola oil diet supplementation on fatty liver in young obese females in Bali
Scientific title
The effect of canola oil diet supplementation on liver steatosis, lipid accumulation product, and fatty liver index in young obese females in Bali
Secondary ID [1] 286978 0
None
Universal Trial Number (UTN)
U1111-1171-5425
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295438 0
Liver steatosis 295439 0
Condition category
Condition code
Diet and Nutrition 295690 295690 0 0
Obesity
Oral and Gastrointestinal 295768 295768 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 ml emulsion consisted of 10 g canola oil (2000 mg linoleic acid (LA), and 1000 mg a-linolenic acid (ALA), n-6:n-3 PUFA ratio 2:1). This intervention was administered once daily. The duration of the intervention was 12 weeks. The mode of administration was oral syrup, monitored weekly by bringing back the bottles. All subjects were recommended for restricted daily energy intake below 1500 kcal and exercise once a week. Diet consultation and exercise were conducted weekly, at the same time of the monitoring.
Intervention code [1] 292186 0
Treatment: Other
Comparator / control treatment
2 gram of palm oil
Control group
Placebo

Outcomes
Primary outcome [1] 295399 0
Changes of lipid accumulation product, assessed by an algorithm based on waist circumference and triglyceride.
Timepoint [1] 295399 0
At 0, 6 and 12 weeks
Primary outcome [2] 295477 0
Changes of fatty liver index, assessed by an algorithm based on BMI, waist circumference, triglyceride and gamma-glutamyl transferase.
Timepoint [2] 295477 0
At 0, 6 and 12 weeks
Primary outcome [3] 295478 0
Changes in liver steatosis, assessed by ultrasonography.
Timepoint [3] 295478 0
At 0 and 12 weeks
Secondary outcome [1] 315511 0
Changes of TNF alpha and IL-10 levels will be determined, measured by ELISA.
Timepoint [1] 315511 0
At 0, 6 and 12 weeks
Secondary outcome [2] 315664 0
Anthropometry changes will be assessed, determined by changes in BMI and waist cricumference.
Timepoint [2] 315664 0
At 0, 6 and 12 weeks

Eligibility
Key inclusion criteria
Obese (BMI > 25kg/m2)
Female
Age 18 - 25 years old
Unmarried
Not necessarily to have liver steatosis
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking pharmacologic and/or herbal regiment to loose weight
Daily intake of antioxidant, vitamins, minerals or other food supplement
Under treatment of chronic disease
Under influence of corticosteroidand/or other anti-inflammatory medicine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered bottles. The pharmacist who prepared the emulsion will write numbers on bottles.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Parallel
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2013
Actual
12/05/2013
Date of last participant enrolment
Anticipated
Actual
2/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 6999 0
Indonesia
State/province [1] 6999 0
Denpasar, Bali

Funding & Sponsors
Funding source category [1] 291537 0
Charities/Societies/Foundations
Name [1] 291537 0
Indonesian Danone Institute Foundation
Country [1] 291537 0
Indonesia
Primary sponsor type
Individual
Name
Dr. I Wayan Weta
Address
Faculty of Medicine, Udayana University, Jl. P.B. Sudirman, Denpasar, Bali 80232
Country
Indonesia
Secondary sponsor category [1] 290216 0
None
Name [1] 290216 0
Address [1] 290216 0
Country [1] 290216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293077 0
Research Ethics Committee of Udayana University/Sanglah Hospital
Ethics committee address [1] 293077 0
Jl. Diponegoro, Denpasar, Bali 80114
Ethics committee country [1] 293077 0
Indonesia
Date submitted for ethics approval [1] 293077 0
Approval date [1] 293077 0
17/09/2012
Ethics approval number [1] 293077 0
787/UN.14.2/ Litbang/2012

Summary
Brief summary
Background: Morbidity of obesity increases in population of most countries as a result of high carbohydrate and fat diet as well as sedentary lifestyle. Lipid accumulation in obesity is associated with non-alcoholic fatty liver disease (NAFLD). This condition is precipitated by a high ratio of n-6:n-3 poly-unsaturated fatty acid (PUFA) commonly found in daily intake of most population. Therefore, diet intervention that might reduce the n6:n3 PUFA ratio would eventually help reduce obesity and improve NAFLD.

Methods: We conducted a triple blind (subjects, assessors, and investigators) randomized clinical trial, involving 66 young obese females in Denpasar, Bali, Indonesia. Subjects were divided into two groups: 33 with (+CO) and 33 without (-CO) canola oil intervention, for 12 weeks. Data were collected before the study (pre), at 6 weeks (mid) and 12 weeks (post). The +CO group was supplemented with 30 ml emulsion consisted of 10 g canola oil (2000 mg linoleic acid (LA), and 1000 mg a-linolenic acid (ALA), n-6:n-3 PUFA ratio 2:1), and the -CO group with 30 ml emulsion of placebo. All subjects were recommended for restricted daily energy intake below 1500 kcal and exercise once a week. Independent variables of body mass index (BMI), waist circumference (WC), triglyceride (TG), and gamma-glutamyl transferase (GGT) were measured. Liver steatosis was assessed using ultrasonography (USG). Lipid accumulation product (LAP) and fatty liver index (FLI) were calculated.

Results: We observed significant decrease of LAP and FLI in the +CO group, respectively. Canola oil supplementation for twelve weeks has prevented and improved liver steatosis of obese subjects. Independently from the intervention, there were strong correlations among LAP, FLI and liver steatosis. Strong correlations were also observed between pre and mid LAP and FLI to post liver steatosis. FLI showed a consistent specific correlation with all stages of liver steatosis, and the correlation was even stronger in higher stage of liver steatosis.

Conclusion: Supplementation of 10 g canola oil daily for 12 weeks decreased LAP, FLI, and liver steatosis in young obese females in Denpasar, Bali, Indonesia. LAP and FLI were good predictors of liver steatosis. However, FLI was a better and more specific predictor for progression of higher stage of liver steatosis when compared to LAP.
Trial website
Trial related presentations / publications
PhD thesis defense.
I Wayan Weta. N-6:N-3 POLYUNSATURATED FATTY ACID RATIO 2:1 DECREASES SERUM TNFalpha AND INCREASES IL10, AS WELL AS IMPROVES FATTY LIVER INDEX IN YOUNG OBESE FEMALES. Poat Graduate Program. Udayana University. 14 July 2014. Denpasar. Bali.
Public notes

Contacts
Principal investigator
Name 58370 0
Dr I Wayan Weta
Address 58370 0
Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232
Country 58370 0
Indonesia
Phone 58370 0
+6281337005360
Fax 58370 0
Email 58370 0
[email protected]
Contact person for public queries
Name 58371 0
Dr I Wayan Weta
Address 58371 0
Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232
Country 58371 0
Indonesia
Phone 58371 0
+6281337005360
Fax 58371 0
Email 58371 0
[email protected]
Contact person for scientific queries
Name 58372 0
Dr I Wayan Weta
Address 58372 0
Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232
Country 58372 0
Indonesia
Phone 58372 0
+6281337005360
Fax 58372 0
Email 58372 0
[email protected]

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