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Trial registered on ANZCTR


Registration number
ACTRN12617000732381
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
19/05/2017
Date last updated
19/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sugar and blackcurrant consumption on the health properties in healthy adults
Scientific title
Effect of sugar and blackcurrant consumption on the bioavailability profile of blackcurrant-derived polypenols and antioxidant capacity in healthy adults.
Secondary ID [1] 288609 0
None
Universal Trial Number (UTN)
U1111-1176-5576
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrient bioavailability 297754 0
Condition category
Condition code
Other 297934 297934 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is aimed at assessing how sugar consumption influences blackcurrant metabolism and antioxidant properties. The trial is a parallel design. This design was selected since the influence of sugar consumption of the time-dependent bioactivity of blackcurrant-derived polyphenolic compounds within the body is currently unknown; a parallel trial design will eliminate any potential problems from a cross-over design.
Participants will be randomised into 3 trial arms; arm 1 will consume a 200 mL blackcurrant drink containing a whole blackcurrant extract equivalent to 3.2 mg polyphenolic compounds /Kg diluted in water, arm 2 will consume a blackcurrant drink (containing the same amount of blackcurrant extract described for arm 1) containing 40 g sucrose and arm 3 will consume a blackcurrant drink (containing the same blackcurrant extract described for arm 1) and then 1 hr later will consume a 200 ml sugar drink containing 40 g sucrose. The blackcurrant extract and sucrose was commercially sourced from Sujon Berries (New Zealand) and Healtheries (New Zealand) and dinks were prepared under New Zealand food safety requirements.
The trial will take place in designated clinical facilitates within PFR and will be conducted by experience trial co-ordinators, who are also First Aider and trained phlebotomist. The trial co-ordinator will monitor the welfare of participants and ensure that they adhere to trial arm protocols.
Participants will be randomised into one of the trial three arms. In all three trial arms a venous blood sample (~ 15 mL) will be taken prior to the consumption blackcurrant +/- sugar drinks, in trial arms 1 and 2, after the consumption of the drinks, blood samples will be collected at 1, 2, 3 and 4 hrs post consumption. In trial 3, blood samples will be taken after both the consumption of the blackcurrant drink and then 1 hr later after the consumption of the sugar drink. In addition, further blood samples will be taken at 2, 3 and 4 hr after the consumption of the initial blackcurrant drink.
Intervention code [1] 294003 0
Treatment: Other
Comparator / control treatment
The control is trial arm 1 which involves the participant consumpting a 200 mL blackcurrant drink consisting of a blackcurrant extract containing the equivalent of 3.2 mg polyphenolic compounds / Kg.
Control group
Active

Outcomes
Primary outcome [1] 297458 0
Collected plasma samples will be measured for the presence of polyphenolic compounds, e.g. anthocyanins using PFR 'in house' HPLC and LC-MS methodologies.
Timepoint [1] 297458 0
Blood is collect prior to the consumption of the blackcurrant +/- sugar drink (time 0) and at 1, 2, 3, and 4 hrs post consumption.
Secondary outcome [1] 321097 0
Collected plasma will be assessed for antioxidant parameters by (i) FRAP using a PFR 'in house' method, (ii) vitamin C and (iii) uric acid using commerically available bioassays.
Timepoint [1] 321097 0
Blood is collect prior to the consumption of the blackcurrant +/- sugar drink (time 0) and at 1, 2, 3, and 4 hrs post consumption.

Eligibility
Key inclusion criteria
Healthy individuals (male or female) aged 16-60 years old. Individuals will be required to complete a health questionnaire and provide informed written consent.
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded if they are unwilling or unable to provide informed written consent or comply with the study procedures. Participants will also be excluded if they have (i) known hypersensitivity or intolerance to blackcurrants or berry fruit-derived products, (ii) health conditions that may affect their ability to regulate sugar digestion/absorption (i.e. diabetes, metabolic syndrome). In addition, participants will be excluded if they are pregnant or planning to get pregnant in the near future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or vial illness, (iv) are taking any mediation that affects the properties of blood (e.g. blood clotting). Furthermore, potential volunteers will be excluded if they have donated blood within 4 weeks from the start of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised in one of the three trial arms. An independent person will allocate participants into one of the three the trial arms together with a subject number. This will then be relayed to the trial co-ordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer sorware - random number generator in window's excel program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In these pilot studies both the investigators and participants will know what treatments (i.e. drinks) they are asked to consume.
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Prior to the onset of the trial a power analysis will be performed on prior unpublished data to determine volunteer size. Prior research in this area by PFR has shown that when examining changes in the plasma fruit-derived polyphenolic compounds, a sample size of 15 has a desired statistical power level of 0.8 with a probability level of 0.05. Data will be analysed using a Statistical Analysis Software (SAS) 9.1 for Windows (version 5.1.2600). Using a repeated measures analysis of variance (ANOVA), comparison between feeding (treatment) groups over time for each measure (independent variable) will also be determined, providing levels of significance for trial effect, treatment effect, and interaction effect between feeding conditions. Post-hoc tests will also be performed to identify significant differences at each time point. Values will be presented as mean +/- standard error at a 95% significance level (p=0.05). Pearson's Product Moment Correlation Coefficient's will also be assessed using SPSS 15.0 for windows to investigate if there are any relationship between certain variables by giving an R-value between 0.0 and 1.00 (or -0.0 and -1.00).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
24/07/2017
Actual
Date of last data collection
Anticipated
4/09/2017
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 7611 0
New Zealand
State/province [1] 7611 0
Manawatu and Waikato

Funding & Sponsors
Funding source category [1] 292955 0
Government body
Name [1] 292955 0
Minstry for Business, Innovation and Employment (MBIE)
Country [1] 292955 0
New Zealand
Funding source category [2] 296444 0
Other
Name [2] 296444 0
The New zealand Institute for Plant and Food Research Ltd.
Country [2] 296444 0
New Zealand
Primary sponsor type
Individual
Name
Jocelyn Eason
Address
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 295396 0
None
Name [1] 295396 0
Address [1] 295396 0
Country [1] 295396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294461 0
HDEC - Northern A Health and Disability Ethics Committee.
Ethics committee address [1] 294461 0
Ethics committee country [1] 294461 0
New Zealand
Date submitted for ethics approval [1] 294461 0
18/11/2015
Approval date [1] 294461 0
14/12/2015
Ethics approval number [1] 294461 0
15/NTA/208

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

Contacts
Principal investigator
Name 63810 0
Dr Suzanne Hurst
Address 63810 0
The New Zealand Institute for Plant and Food Research Ltd.,
Private Bag 11600,
Palmerston North 4442
Country 63810 0
New Zealand
Phone 63810 0
+64 6 355 6231
Fax 63810 0
+64 6 351 7050
Email 63810 0
[email protected]
Contact person for public queries
Name 63811 0
Roger Hurst
Address 63811 0
The New Zealand Institute for Plant and Food Research Ltd.,
Private Bag 11600,
Palmerston North 4442
Country 63811 0
New Zealand
Phone 63811 0
+ 64 6 953 7677
Fax 63811 0
+64 6 351 7050
Email 63811 0
[email protected]
Contact person for scientific queries
Name 63812 0
Suzanne Hurst
Address 63812 0
The New Zealand Institute for Plant and Food Research Ltd.,
Private Bag 11600,
Palmerston North 4442
Country 63812 0
New Zealand
Phone 63812 0
+ 64 6 355 6231
Fax 63812 0
+ 64 6 351 7050
Email 63812 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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