Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000012976
Ethics application status
Approved
Date submitted
15/11/2010
Date registered
6/01/2011
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Microencapsulation for Enhanced Bioavailability of Fish Oil - Acute Study
Scientific title
Microencapsulation for Enhanced Bioavailability of Fish Oil in Healthy Adult Volunteers - Acute Study
Secondary ID [1] 253022 0
None
Universal Trial Number (UTN)
Trial acronym
BF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioavailabilty of microencapsulated omega-3 oil as a dietary supplement 258585 0
Condition category
Condition code
Diet and Nutrition 258721 258721 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the short term bioavailability of 3 delivery systems containing omega-3 oils. They are (1) gel capsules versus (2) MicroMAX 1 powder – formulated with milk protein-sugar versus (3) MicroMAX powder - formulated with milk protein-sugar-resistant starch) when combined with a flavoured milk in individuals. Bioavailability will be assessed by measurement of EPA & DHA in blood/plasma.

This is a crossover design study in which all participants will receive the three treatments with a washout period of 6 weeks between each treatment.

To investigate the bioavailability of a single dose of omega-3 oils delivered via the three above mentioned formats over 48 hrs. The two different MicroMAX powders (one formulated with milk protein-sugar and other milk protein-sugar-resistant starch) will each be provided as an 8g serve containing a dose of 500mg/g omega-3 oil. The gel capsules will be given as a one-off dose of 4 capsules (each capsule will contain 1000mg of omega-3 oil).
Intervention code [1] 257549 0
Treatment: Other
Comparator / control treatment
Being a bioavailabilty study the comparison to commonly available gel capsules will be considered the bench mark or comparator treatment to the 2 microencapsulated products. The subjects for this study have been recruited from existing database of past study volunteers.
Control group
Active

Outcomes
Primary outcome [1] 259587 0
Plasma total fatty acids at each appropriate time point.
Timepoint [1] 259587 0
As a crossover design this study will focus on acute response of ingestion of the 3 test products as measured in plasma free fatty acids. Baseline measurements will be taken at timepoint 0, then at 2, 4, 6, 24 and 48 hours post ingestion for each treatment. Each treatment is given on one occasion with 6 weeks between treatments.
Secondary outcome [1] 266218 0
Acute response study: Red blood cell membrane fatty acids at t=0 weeks to monitor accumulation of membrane DHA/EPA over the 3 treatments.
Timepoint [1] 266218 0
Acute response study: as a crossover design this study will focus on acute response of ingestion of the 3 test products. secondary outcomes listed above.

Eligibility
Key inclusion criteria
1. Male and Females aged between 18-70 years
2. Normal dietary habits (no medically prescribed diet, no slimming diet, and no vegan or macrobiotic diet).
3. Body Mass Index >18 kg/m2 < 35kg/m2
4. Apparently healthy: no reported current or previous metabolic diseases, gastrointestinal disorders, renal or cardiovascular disease.
5. Person having given their specific consent in writing.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Regular use of supplements containing omega-3 essential fatty acids must have ceased 2 months prior to the start of the study.
2. Regular consumption of foods supplemented with omega-3 essential fatty acids such as some breads and milk products
3. Consumption of fish as part of regular dietary patterns
4. Current relevant medical treatment (subject to judgement of the investigator).
5. High alcohol consumption (>21 standard drinks/week)
6. Reported participation in another biomedical trial 3 months before the start of the study or during the study.
7. Food allergies or intolerances (dairy, lactose, peanuts, shellfish, etc…).
8. Recent history (within 12 months) of substance abuse including alcohol abuse.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects recruited from existing database of past study volunteers. Volunteers will be randomised to a treatment using Clinstat randomisation programme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258001 0
Other Collaborative groups
Name [1] 258001 0
CSIRO Preventative Health Flagship
Country [1] 258001 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSIRO Preventative Health Flagship
Address
CSIRO Food and Nutritional Sciences, PO box 10041 Adeliade SA 5000
Country
Australia
Secondary sponsor category [1] 257196 0
None
Name [1] 257196 0
Address [1] 257196 0
Country [1] 257196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259995 0
CSIRO Food and Nutritional Sciences Human Research Ethics Committee
Ethics committee address [1] 259995 0
Gate 13 Kintore Avenue
ADELAIDE
South Australia 5000
Ethics committee country [1] 259995 0
Australia
Date submitted for ethics approval [1] 259995 0
Approval date [1] 259995 0
14/09/2010
Ethics approval number [1] 259995 0
10/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31629 0
Address 31629 0
Country 31629 0
Phone 31629 0
Fax 31629 0
Email 31629 0
Contact person for public queries
Name 14876 0
Peter Royle
Address 14876 0
C/- CSIRO Food and Nutritional Sciences
PO box 10041 Adelaide BC 5000
Country 14876 0
Australia
Phone 14876 0
+61 8 83038947
Fax 14876 0
Email 14876 0
[email protected]
Contact person for scientific queries
Name 5804 0
Mahinda Abeywardena
Address 5804 0
C/- CSIRO Food and Nutritional Sciences
PO box 10041 Adelaide BC 5000
Country 5804 0
Australia
Phone 5804 0
+61 8 8303 8800
Fax 5804 0
Email 5804 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.