Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000907246
Ethics application status
Approved
Date submitted
5/10/2009
Date registered
20/10/2009
Date last updated
15/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of fruit constituents on gut health in healthy adult volunteers
Scientific title
The effect of polyphenolic fruit extracts and fibre on gut health in healthy adult volunteers
Secondary ID [1] 284445 0
Nil known
Universal Trial Number (UTN)
U1111-1111-0019
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gut health 251926 0
problems with gut health 251927 0
Condition category
Condition code
Diet and Nutrition 252111 252111 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 252157 252157 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
arm 1 - a 300ml polyphenol beverage containing 500mg polyphenols taken in 2 doses in a day for 4 weeks, arm 2- a 300ml fibre beverage containing 7.5g fibre taken in 2 doses in a day for 4 weeks, and arm 3 - a 300ml polyphenol and fibre beverage containing 500mg polyphenols and 7.5g fibre taken in 2 doses in a day for 4 weeks, with a 2 week washout period between each intervention
Intervention code [1] 241349 0
Prevention
Comparator / control treatment
placebo - a 300ml sugar beverage taken in 2 doses in a day for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 252991 0
effect on measures of gut health including quantification of various groups of bacteria in faeces
Timepoint [1] 252991 0
0 and Four weeks
Primary outcome [2] 253024 0
effect on short chain fatty analysis in faeces
Timepoint [2] 253024 0
0 and four weeks
Primary outcome [3] 253025 0
effect on faecal transit time in faeces using capsule marker
Timepoint [3] 253025 0
0 and four weeks
Primary outcome [4] 253026 0
effect on faecal nitrogenous end points
Timepoint [4] 253026 0
0 and 4 weeks
Secondary outcome [1] 257758 0
effect on gut regularity as measured by a questionnaire
Timepoint [1] 257758 0
Daily for four weeks following randomisation
Secondary outcome [2] 257839 0
effect on bowel motions as measured by a questionnaire
Timepoint [2] 257839 0
daily for four weeks following randomisation
Secondary outcome [3] 257840 0
effect on general well being as measured by a questionnaire
Timepoint [3] 257840 0
daily for four weeks following randomisation

Eligibility
Key inclusion criteria
Body mass index between 18 and 35kg/m2
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
They must not have a history of drug or alcohol abuse, be pregnant or breastfeeding, have any gut-related problems (except irritable bowel syndrome), diabetes mellitus, vascular disease, a mental illness, hepatitis, a compromised immune status and they must not have or have had cancer. They must not have anaemia, malnutrition from malabsorption, regularly use anti-inflammatory drugs, consume vitamin or mineral supplements, take fermented milk drinks such as Yakult or take fibre supplements such as Metamucil. They also must not be undertaking extreme exercise or suffer from exercise-related diarrhoea.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Bottles of drink labelled by numbers only, people giving them the bottles and those receiving bottles blinded to what treatment on
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of four treatments will be allocated to subjects so that they follow a complete unbalanced latin square design with all possible sequences (24) of 4 treatments adopted. The remaining 6 subjects will be allocated randomly to 6 unique sequences of the 24 by computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
1/05/2010
Date of last participant enrolment
Anticipated
31/07/2010
Actual
31/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2158 0
New Zealand
State/province [1] 2158 0

Funding & Sponsors
Funding source category [1] 243805 0
Government body
Name [1] 243805 0
Foundation for Research, Science and Technology of New Zealand
Country [1] 243805 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant & Food Research Limited
Address
Private Bag 4704
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 237157 0
None
Name [1] 237157 0
Address [1] 237157 0
Country [1] 237157 0
Other collaborator category [1] 882 0
Other Collaborative groups
Name [1] 882 0
Lipid and Diabetes Research Group
Address [1] 882 0
PO Box 4710,
Christchurch 8140
Country [1] 882 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243936 0
Upper South A Ethics Committee
Ethics committee address [1] 243936 0
Ethics committee country [1] 243936 0
New Zealand
Date submitted for ethics approval [1] 243936 0
05/10/2009
Approval date [1] 243936 0
01/04/2010
Ethics approval number [1] 243936 0
URA/09/10/073

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

Contacts
Principal investigator
Name 30335 0
Dr Alison Wallace
Address 30335 0
New Zealand Institute for Plant & Food Research
Private Bag 4704 Christchurch 8140
Country 30335 0
New Zealand
Phone 30335 0
+6433256400
Fax 30335 0
Email 30335 0
[email protected]
Contact person for public queries
Name 13582 0
Alison Wallace
Address 13582 0
Private Bag 4704
Christchurch 8140
Country 13582 0
New Zealand
Phone 13582 0
+6433259638
Fax 13582 0
+6433252074
Email 13582 0
[email protected]
Contact person for scientific queries
Name 4510 0
Alison Wallace
Address 4510 0
Private Bag 4704
Christchurch 8140
Country 4510 0
New Zealand
Phone 4510 0
+6433259638
Fax 4510 0
+6433252074
Email 4510 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
SourceTitleYear of PublicationDOI
EmbaseConsumption of apple-boysenberry beverage decreases salivary Actinomyces naeslundii and their adhesion in a multi-species biofilm model.2017https://dx.doi.org/10.3920/BM2016.0061
N.B. These documents automatically identified may not have been verified by the study sponsor.