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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000757516 |
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Date of registration:
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21/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of canola oil diet supplementation on fatty liver in young obese females in Bali
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Scientific title:
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The effect of canola oil diet supplementation on liver steatosis, lipid accumulation product, and fatty liver index in young obese females in Bali |
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Date of first enrolment:
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12/05/2013 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000757516.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);
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Phase:
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Not Applicable
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Dr I Wayan Weta
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Address:
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Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232
Indonesia |
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Telephone:
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+6281337005360 |
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Email:
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wayan_weta06@yahoo.co.id |
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Affiliation:
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Name:
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Dr I Wayan Weta
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Address:
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Faculty of Medicine, Udayana University
Jl. PB Sudirman, Denpasar, Bali 80232
Indonesia |
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Telephone:
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+6281337005360 |
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Email:
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wayan_weta06@yahoo.co.id |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Obese (BMI > 25kg/m2)
Female
Age 18 - 25 years old
Unmarried
Not necessarily to have liver steatosis
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
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Obesity;Liver steatosis;
Obesity
Liver steatosis
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Diet and Nutrition - Obesity
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Intervention(s)
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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.
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Primary Outcome(s)
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Changes of lipid accumulation product, assessed by an algorithm based on waist circumference and triglyceride.[At 0, 6 and 12 weeks]
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Changes in liver steatosis, assessed by ultrasonography.[At 0 and 12 weeks]
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Changes of fatty liver index, assessed by an algorithm based on BMI, waist circumference, triglyceride and gamma-glutamyl transferase.[At 0, 6 and 12 weeks]
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Secondary Outcome(s)
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Changes of TNF alpha and IL-10 levels will be determined, measured by ELISA.[At 0, 6 and 12 weeks]
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Anthropometry changes will be assessed, determined by changes in BMI and waist cricumference.[At 0, 6 and 12 weeks]
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Source(s) of Monetary Support
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Indonesian Danone Institute Foundation
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Ethics review
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Status: Approved
Approval date:
Contact:
Research Ethics Committee of Udayana University/Sanglah Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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