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Trial registered on ANZCTR


Registration number
ACTRN12617000733370
Ethics application status
Approved
Date submitted
15/05/2017
Date registered
19/05/2017
Date last updated
19/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Delayed effect of blackcurrant consumption on sugar metabolism in healthy adults
Scientific title
Delayed effect of blackcurrant consumption on the regulation of sugar metabolism and energy production in healthy adults.
Secondary ID [1] 291952 0
None
Universal Trial Number (UTN)
U1111-1176-5576
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sugar Regulation 303300 0
Condition category
Condition code
Metabolic and Endocrine 302733 302733 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is aimed at assessing the delayed action of blackcurrant consumption on sugar metabolism and energy production. The trial is a parallel design consisting of two trial arms. This design was selected since the influence of blackcurrant on sugar metabolism is currently unknown; a parallel trial design will eliminate any potential problems from a cross-over design.
In both trial arms, participants will be asked to fast for 12 hrs the night before and eat a set breakfast (One Square Meal Bar [Cookie Time Ltd.]) 2 hrs before the start of the trial. Participants will be randomised into 2 trial arms; arm 1 will consume a 200 mL drink containing fruit sugar (equivalent to the amount in the blackcurrant extract, i.e. for 2.2 g glucose, 2.6 g fructose, 0.36 g sucrose) diluted in water and then 3 hr later a 200 ml sugar drink containing 40 g sucrose diluted in water, and arm 2 will consume a 200 ml a blackcurrant drink (containing a whole blackcurrant extract equivalent to 3.2 mg polyphenolic compounds /Kg) diluted in water and then 3 hrs later a 200 ml sugar drink containing 40 g sucrose diluted in water.
The blackcurrant extract was commercially sourced from Sujon Berries (New Zealand) and the sugars purchased from 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 two arms. In both arms a small amount of blood (capillary samples) will be taken prior to the start of the trial, 3hrs after the consumption fruit sugar or blackcurrant drinks and at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins after the sucrose drink..
Intervention code [1] 298080 0
Treatment: Other
Comparator / control treatment
The control is trial arm 1 which involves the participant consuming a 200 mL fruit sugar drink (equivalent to the amount of sugar found in the blackcurrant drink) and then 3 hrs later a 200 mL sugar drink, which contains 40 g sucrose.
Control group
Active

Outcomes
Primary outcome [1] 302126 0
Collected blood samples will be analysed for glucose by 'point of test' biosensors
Timepoint [1] 302126 0
Blood is collected at the start of the trial, 3 hrs after consumption of either the fruit sugar (trial arms 1) or blackcurrant (trial arm 2) drink, and then at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins, after the consumption of the sugar drink.
Primary outcome [2] 302127 0
Collected plasma will be analysed for insulin using commerical ELISAs.
Timepoint [2] 302127 0
Blood is collected at the start of the trial, 3 hrs after consumption of either the fruit sugar (trial arms 1) or blackcurrant (trial arm 2) drink, and then at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins, after the consumption of the sugar drink.
Secondary outcome [1] 334894 0
Collected blood samples will be analysed for lactate by 'point of test' biosensors
Timepoint [1] 334894 0
Blood is collected at the start of the trial, 3 hrs after consumption of either the fruit sugar (trial arms 1) or blackcurrant (trial arm 2) drink, and then at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins, after the consumption of the sugar drink.
Secondary outcome [2] 335019 0
Collected blood samples will be analysed for ATP using commerically available bioassays
Timepoint [2] 335019 0
Blood is collected at the start of the trial, 3 hrs after consumption of either the fruit sugar (trial arms 1) or blackcurrant (trial arm 2) drink, and then at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins, after the consumption of the sugar drink.
Secondary outcome [3] 335020 0
Collected plasma will be analysed for glucagon using commerical ELISAs.
Timepoint [3] 335020 0
Blood is collected at the start of the trial, 3 hrs after consumption of either the fruit sugar (trial arms 1) or blackcurrant (trial arm 2) drink, and then at specific times over a 2 hr period; 15, 30, 45, 60, 90 & 120 mins, after the consumption of the sugar drink.

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 two trial arms. An independent person will allocate participants into one of the two 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
Efficacy
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 blood glucose in response to a sugar drink containing 40 g sucrose, 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 a 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
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8903 0
New Zealand
State/province [1] 8903 0
Waikato and Manawatu

Funding & Sponsors
Funding source category [1] 296466 0
Government body
Name [1] 296466 0
Minstry for Business, Innovation and Employment (MBIE)
Country [1] 296466 0
New Zealand
Funding source category [2] 296467 0
Other
Name [2] 296467 0
The New Zealand Institute for Plant and Food Research Ltd.
Country [2] 296467 0
New Zealand
Primary sponsor type
Other
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] 295421 0
None
Name [1] 295421 0
Address [1] 295421 0
Country [1] 295421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297689 0
HDEC - Northern A Health and Disability Ethics Committee
Ethics committee address [1] 297689 0
Ethics committee country [1] 297689 0
New Zealand
Date submitted for ethics approval [1] 297689 0
18/11/2015
Approval date [1] 297689 0
14/12/2015
Ethics approval number [1] 297689 0
15/NTA/208

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

Contacts
Principal investigator
Name 74834 0
Dr Suzanne Hurst
Address 74834 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600,
Palmerston North 4442
Country 74834 0
New Zealand
Phone 74834 0
+64 6 355 6231
Fax 74834 0
+64 6 351 7050
Email 74834 0
[email protected]
Contact person for public queries
Name 74835 0
Roger Hurst
Address 74835 0
The New Zealand Institute for Plant and Food Research Ltd.,
Private Bag 11600,
Palmerston North 4442
Country 74835 0
New Zealand
Phone 74835 0
+ 64 6 953 7677
Fax 74835 0
+64 6 351 7050
Email 74835 0
[email protected]
Contact person for scientific queries
Name 74836 0
Suzanne Hurst
Address 74836 0
The New Zealand Institute for Plant and Food Research Ltd.,
Private Bag 11600,
Palmerston North 4442
Country 74836 0
New Zealand
Phone 74836 0
+64 6 355 6231
Fax 74836 0
+64 6 351 7050
Email 74836 0
[email protected]

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