ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1171-5425

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Liver steatosis

Condition category

Condition code

Diet and Nutrition

Obesity

Oral and Gastrointestinal

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]

Treatment: Other

Comparator / control treatment

2 gram of palm oil

Control group

Placebo

Outcomes

Primary outcome [1]

Changes of lipid accumulation product, assessed by an algorithm based on waist circumference and triglyceride.

Timepoint [1]

At 0, 6 and 12 weeks

Primary outcome [2]

Changes of fatty liver index, assessed by an algorithm based on BMI, waist circumference, triglyceride and gamma-glutamyl transferase.

Timepoint [2]

At 0, 6 and 12 weeks

Primary outcome [3]

Changes in liver steatosis, assessed by ultrasonography.

Timepoint [3]

At 0 and 12 weeks

Secondary outcome [1]

Changes of TNF alpha and IL-10 levels will be determined, measured by ELISA.

Timepoint [1]

At 0, 6 and 12 weeks

Secondary outcome [2]

Anthropometry changes will be assessed, determined by changes in BMI and waist cricumference.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Indonesia

State/province [1]

Denpasar, Bali

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Indonesian Danone Institute Foundation

Address [1]

Cyber 2 Tower 9th Floor, Jl. H.R. Rasuna Said Blok X-5 No. 13, Jakarta 12950

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics Committee of Udayana University/Sanglah Hospital

Ethics committee address [1]

Jl. Diponegoro, Denpasar, Bali 80114

Ethics committee country [1]

Indonesia

Date submitted for ethics approval [1]

Approval date [1]

17/09/2012

Ethics approval number [1]

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

Dr I Wayan Weta

Address

Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232

Country

Indonesia

Phone

+6281337005360

Fax

wayan_weta06@yahoo.co.id

Contact person for public queries

Name

I Wayan Weta

Address

Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232

Country

Indonesia

Phone

+6281337005360

Fax

wayan_weta06@yahoo.co.id

Contact person for scientific queries

Name

I Wayan Weta

Address

Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232

Country

Indonesia

Phone

+6281337005360

Fax

wayan_weta06@yahoo.co.id

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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