Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000385549
Ethics application status
Approved
Date submitted
5/03/2015
Date registered
28/04/2015
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Profiling bioavailable berry polyphenols in humans
Scientific title
Profiling of specific berry-fruit derived polyphenol metabolites in plasma and urine of healthy adult humans fed blueberry or boysenberry extract
Secondary ID [1] 286319 0
Nil
Universal Trial Number (UTN)
U1111-1167-4904
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Health and wellbeing 294416 0
Cardiovascular Disease 294484 0
Condition category
Condition code
Public Health 294725 294725 0 0
Other public health
Cardiovascular 294788 294788 0 0
Normal development and function of the cardiovascular system
Cardiovascular 294790 294790 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Blueberry extract
Arm 2: Boysenberry extract

Special Note: We have reconsidered the use of whole fruit and have excluded this from the current protocol. An extract of the fruit only will be used and this will be administered in 250 mL liquid form.

Intervention details

Dose: 250 mL extract of blueberry or boysenberry

Duration: One-off administration

Lead-in dietary washout phase: Up to 1-week of low polyphenol diet

Mode of administration: Oral

Samples collected: Baseline (overnight-fasted), and postprandial (0.5, 1, 2, 4, 6, 8, 9, 12, and 24h) blood samples, and, 0-24 h urine samples


Analytical technique: High performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) for compliance check and detection, identification, and quantification of selected juice-derived polyphenol metabolites
Intervention code [1] 291362 0
Treatment: Other
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294488 0
Precise identities and circulating concentrations of berry-fruit derived polyphenol metabolites established in postprandial plasma and urine after intake of blueberry or boysenberry extract
Timepoint [1] 294488 0
At baseline (After overnight fast), 0.5, 1, 2, 4, 6, 8, 9, 12, and 24 hours after intake of blueberry or boysenberry extract
Secondary outcome [1] 313439 0
Not applicable
Timepoint [1] 313439 0
Not applicable

Eligibility
Key inclusion criteria
Healthy males/females aged 18 or older, non-smokers, non-pregnant, and residing in Auckland for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Declare themselves unhealthy, drink alcohol excessively, are (or are seeking to become) pregnant, are currently taking recreation/over-the-counter/prescription medication (excluding contraceptive pills and other select pills)/dietary and herbal supplements, have any food allergies or sensitivities, have a history of/current head trauma, ADHD (Attention Deficient Hyperactivity Disorder), dyslexia, migraines or any gastric problems, have a history of eating disorders (anorexia nervosa, bulimia, etc.), suffer from or have a history of clinical hypertension, have a BMI over 39 (morbidly obese), have fainting issues due to venipuncture, do not have good understanding of English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2015
Actual
20/05/2015
Date of last participant enrolment
Anticipated
Actual
21/11/2015
Date of last data collection
Anticipated
Actual
15/06/2016
Sample size
Target
20
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 6719 0
New Zealand
State/province [1] 6719 0
Auckland

Funding & Sponsors
Funding source category [1] 290890 0
University
Name [1] 290890 0
Auckland Uniservices Ltd. (The University of Auckland)
Country [1] 290890 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Research Integrity Unit (Building 620),
49 Symonds Street, Level 10,
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289571 0
Other Collaborative groups
Name [1] 289571 0
Centre for Free Radical Research (University of Otago)
Address [1] 289571 0
Centre for Free Radical Research
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
Country [1] 289571 0
New Zealand
Other collaborator category [1] 278388 0
Individual
Name [1] 278388 0
Dr. Arjan Scheepens
Address [1] 278388 0
Plant and Food Research
120 Mt Albert Road, Sandringham, Auckland 1025
Country [1] 278388 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292490 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 292490 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON, 6011
Ethics committee country [1] 292490 0
New Zealand
Date submitted for ethics approval [1] 292490 0
06/03/2015
Approval date [1] 292490 0
13/04/2015
Ethics approval number [1] 292490 0
15/NTA/46

Summary
Brief summary
Preliminary evidence from human intervention studies support a potential role of berries and their processed products in risks mitigation of inflammatory diseases (Joseph et al., 2014) and cardiovascular diseases (CVDs) (Rodriguez-Mateos et al., 2014).
Despite these, owing to limited studies that assessed the absorption and metabolism of berry (poly)phenols, at present, it remains unclear whether it is the native (unmetabolized) berry polyphenols, their in vivo metabolic breakdown products, or a combination of the two, that are responsible for attributing the cardiovascular health benefits associated with consumption of berry products. As such, to enable the establishment of potential cause-and-effect relationships, the current literature recommends the need for more research efforts to clarify which specific berry (poly)phenols are directly responsible for the observed in vivo beneficial actions on cardiovascular health.
In addition, it is unclear whether consumption of berry species with some subtle differences in (poly)phenol composition would give rise to some common in vivo plasma and/or urinary metabolite profiles. This information is critical as it would help explain whether observed differences in some measurable clinical endpoints of CVDs derived from consumption of different berry species is fundamentally associated to differences in the in vivo (poly)phenol metabolite profiles.
Our Hypothesis: Based on information from the current literature, we hypothesize that some (poly)phenolic breakdown products are common in vivo metabolites that are formed postprandially, regardless of subtle differences in berry (poly)phenol composition, and that these (poly)phenolic metabolites (as opposed to the native polyphenols found in berry extracts) are partly responsible for upregulating in vivo mechanisms that lead towards some measurable beneficial cardiovascular health outcomes in humans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55574 0
Prof Margreet Vissers
Address 55574 0
Centre for Free Radical Research,
University of Otago,
2 Riccarton Ave,
Christchurch 8011, New Zealand
Country 55574 0
New Zealand
Phone 55574 0
+64 3 364 1524
Fax 55574 0
Email 55574 0
[email protected]
Contact person for public queries
Name 55575 0
Prof Margreet Vissers
Address 55575 0
Centre for Free Radical Research,
University of Otago,
2 Riccarton Ave,
Christchurch 8011, New Zealand
Country 55575 0
New Zealand
Phone 55575 0
+64 3 364 1524
Fax 55575 0
Email 55575 0
[email protected]
Contact person for scientific queries
Name 55576 0
Prof Margreet Vissers
Address 55576 0
Centre for Free Radical Research,
University of Otago,
2 Riccarton Ave,
Christchurch 8011, New Zealand
Country 55576 0
New Zealand
Phone 55576 0
+64 3 364 1524
Fax 55576 0
Email 55576 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

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