Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000762853
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
18/07/2012
Date last updated
23/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Probiotics on Gut Microflora and the Metabolism of Orange Juice Flavonoids
Scientific title
Impact of Probiotics on Gut Microflora and the Metabolism of Orange Juice Flavonoids in Healthy Participants
Secondary ID [1] 280691 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The impact of microencapsulated probiotics on the gut microflora, and on the absorption and metabolism of ingested orange juice flavanones in healthy individuals. 286679 0
Condition category
Condition code
Diet and Nutrition 286982 286982 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 287271 287271 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
24 participants will be recruited.

There will be three intervention phases.

72 hours prior to the first probiotic intervention, participants will commence a 4-day duration of a special low polyphenol diet (avoiding fruits and vegetables, including those in prepared dishes, and juices thereof, tea coffee, drinking chocolate, alcohol (especially red wine, beer and apple cider)), chocolate and chocolate products, cereals, grains, wholemeal bread, spices (such as curry) and herbs.
For 24 hours prior to the first probiotic intervention participants will collect a full urine save.

Participants will fast (water allowed as required) from 10 pm the evening prior to their attendance at the clinical research unit.

On that first intervention morning, participants will attend the clinic in a fasted state and complete a 24 hour urine save upon arrival.

Participants will then consume a 350 ml serving of orange juice plus a single dose (up to 5 g) of probiotic in an encapsulated format (MicroMAX Pro (Registered Trademark)) and commence collecting urine for a period of 2 hours while remaining in the clinic. The 5 g dose of encapsualted probiotic is equivalent to a daily dose of probiotic containing between 1 billion and 10 billion colony forming units, which is the amount recommended by most authories.

After the 2 hour visit is complete, participants will be free to leave, but will still follow the low polyphenol diet until 8 am the following morning. Participants will also be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours.

Following the first intervention visit and until the completion of the study, participants will be instructed to avoid probiotic-enriched foods.

After a period of ~26 days volunteers will again commence a 4 day low-polyphenol diet and will also collect a full 24 hour urine save prior to attending the clinic. In addition, faecal samples will be collected for a full 48 hour period prior to the intervention. Participants will again arrive at the clinic in a fasted state (from 10 pm the evening prior), when they will complete their 24 hour urine collection and then consume a 350 ml serve of orange juice.

After the 2 hour visit is complete, participants will be free to leave, but will still follow the low polyphenol diet until 8 am the following morning. Participants will also be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours. A 24 day supply of probiotic supplements (up to 5g per day) will be supplied to each volunteer who will be instructed to consume one supplement per day for the next 24 days. Participants will collect full 48 hour faecal saves at the end of each week for the following 4 weeks – providing a total of five 48 hour faecal collections for the study.

After 21 days on the probiotic supplement (up to 5g per day), volunteers will continue to take the supplement and commence a four day low-polyphenol diet. They will also collect a full 24 hour urine save prior to their third and final clinic visit for the third intervention. Participants will arrive at the clinic in a fasted state (from 10 pm the evening prior and having had no supplement that morning), when they will complete their 24 hour urine collection and then consume a 350 ml serve of flavanone-enriched orange juice plus a single dose of probiotic (up to 5g).

After the 2 hour visit is complete, participants will be free to leave, but will be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours.
Participants will continue to follow the low polyphenol diet while collecting the urine save until 8 am the following morning.

All participants will record their supplement intake on a daily checklist and will also record any deviations from the 4 day low-polyphenol diet and any accidental intake of probiotic enriched foods.
Intervention code [1] 285067 0
Treatment: Other
Comparator / control treatment
Participants are their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287319 0
Analysis of the flavanone catabolites in urine prior to, and after consumption of the orange juice, and before and after the course of microencapsulated probiotics.
Timepoint [1] 287319 0
Measured in urine samples collected 24 hours prior to and 24 hours post each of the three 2-hour clinic attendances.
Secondary outcome [1] 297897 0
Quantitative evaluation of the effective delivery of the microencapsulated probiotics to and colonisation of the large intestine by examination of the coliforms present and abundance of the specific probiotic species delivered in faecal material collected prior to, during, and at the end of a 3 week course of the microencapsulated probiotic.
Genotoxicity analysis of the faecal water prior to, and after consumption of the orange juice, and before and after the course of microencapsulated probiotics.
Timepoint [1] 297897 0
Measured in faecal samples collected prior to the long ingestion phase (25 day duration) of the probiotic supplement and also at weekly intervals for the 4 weeks post the long ingestion phase.

Eligibility
Key inclusion criteria
1. Male and females aged between 18-70 years.
2. Normal dietary habits (no medically prescribed diet, not taking vitamin, probiotic, prebiotic, or antioxidant supplements, no slimming diet, and no vegan or macrobiotic diet).
3. Body Mass Index > 18 kg/m2 < 35 kg/m2 (calculation: Body Mass Index = weight in kg / height2 in 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 probiotics within two months prior to the start of the study.
2. Regular consumption of foods supplemented with probiotics such as some breads and milk products within 2 months prior to the start of the study.
3. Current medical treatment or medication that may interfere with the study (this will be assessed from the medical questionnaire).
4. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
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.
9. Intolerance to probiotics or orange juice.
10. Pregnant.
11. Smokers.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited by advertisement in local press. Volunteers will be screened for eligibility and then invited to join the study. All volunteers to receive the same supplement so no randomisation or allocation to treatment is required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285430 0
Government body
Name [1] 285430 0
CSIRO Preventative Health National Research Flagship - Colorectal Cancer Theme.
Country [1] 285430 0
Australia
Primary sponsor type
Government body
Name
CSIRO Preventative Health National Research Flagship – Colorectal Cancer Theme
Address
Preventative Health

Level 3, Elizabeth House 231 North Terrace

Adelaide SA 5000

Australia
Country
Australia
Secondary sponsor category [1] 284282 0
None
Name [1] 284282 0
Address [1] 284282 0
Country [1] 284282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287439 0
CSIRO Food and Nutritional Sciences (CFNS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 287439 0
Ethics committee country [1] 287439 0
Australia
Date submitted for ethics approval [1] 287439 0
09/01/2012
Approval date [1] 287439 0
09/01/2012
Ethics approval number [1] 287439 0
11/17

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

Contacts
Principal investigator
Name 34302 0
Address 34302 0
Country 34302 0
Phone 34302 0
Fax 34302 0
Email 34302 0
Contact person for public queries
Name 17549 0
Luz Sanguansri
Address 17549 0
CSIRO Animal, Food and Health Sciences
671 Sneydes Rd
Werribee
VIC 3030
Country 17549 0
Australia
Phone 17549 0
+61 03 9731 3228
Fax 17549 0
Email 17549 0
[email protected]
Contact person for scientific queries
Name 8477 0
Christine Oliver
Address 8477 0
CSIRO Animal, Food and Health Sciences
671 Sneydes Rd
Werribee
VIC 3030
Country 8477 0
Australia
Phone 8477 0
+61 03 9731 3458
Fax 8477 0
Email 8477 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
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Results publications and other study-related documents

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