Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001367730p
Ethics application status
Not yet submitted
Date submitted
20/10/2022
Date registered
25/10/2022
Date last updated
25/10/2022
Date data sharing statement initially provided
25/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The metabolism of crab apple ascorbyl 2-beta-glucoside (AA2ßG) to Vitamin C in healthy individuals
Scientific title
Investigating the metabolic conversion of crab apple-derived ascorbyl 2-beta-glucoside (AA2ßG) to Vitamin C by characterising the bioavailability of Vitamin C after consuming a single dose of crab apple juice in healthy individuals
Secondary ID [1] 308214 0
Nil
Universal Trial Number (UTN)
U1111-1284-1008
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin C deficiency 327965 0
Condition category
Condition code
Diet and Nutrition 325028 325028 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 3 interventions being studied are apple juice.
1) Apple juice – is pressed commercial apple juice
2) Apple juice + crab apple juice - is a mix of apple juice and crab apple juice (23% and 77% respectively) the crab apple juice has naturally occurring ascorbyl 2-beta glucoside
3) Apple juice + ascorbic acid - is apple juice plus 85 mg of food grade ascorbic acid
This study is a three-arm crossover study. Each intervention will be delivered randomly, weekly, over three Trial Days – one Trial Day for each apple juice intervention (Apple juice, Apple juice + crab apple juice, Apple juice + ascorbic acid).
The trial co-ordinator will deliver the apple juice.
Participants will consume 300 g of apple juice, consuming within 2 minutes, in a face to face clinical setting, at Plant and Food Research Institute, Palmerston North, New Zealand
Intervention code [1] 324677 0
Treatment: Other
Comparator / control treatment
The control is drink 1) Apple juice – is pressed commercial apple juice. This control will be used as a negative control. This control apple juice contains no AA2ßG and very low levels of ascorbic acid.
Control group
Active

Outcomes
Primary outcome [1] 332851 0
Ascorbic acid concentration change in plasma measured by UHPLC analysis
Timepoint [1] 332851 0
Plasma measurement at baseline, and 1, 2, 3, 4 hours after intervention dose
Primary outcome [2] 332852 0
AA2ßG concentration change in plasma measured by UHPLC analysis
Timepoint [2] 332852 0
Plasma measurement at baseline, and 1, 2, 3, 4 hours after intervention dose
Primary outcome [3] 332910 0
Ascorbic acid concentration change in urine measured by UHPLC analysis
Timepoint [3] 332910 0
Urine measurement at baseline, 2 and 4 hours after intervention dose
Secondary outcome [1] 414869 0
Primary Outcome: AA2ßG concentration change in urine measured by UHPLC analysis
Timepoint [1] 414869 0
Primary timepoint: Urine measurement at baseline, 2 and 4 hours after intervention dose

Eligibility
Key inclusion criteria
Healthy individual of any gender
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• have a chronic disease (heart disease, cancer, kidney failure, diabetes or conditions relating to the nervous system (e.g. multiple sclerosis, spinal cord injury, stroke)
• have a blood borne disease (e.g. hepatitis)
• are pregnant, breastfeeding or planning a pregnancy in the immediate future
• have a known intolerance, sensitivity or allergy to apples
• are taking medication that affects the properties of blood (e.g. blood clotting) or immune function
• have a strong reaction to having a blood sample taken from you (e.g. fainting, severe anxiety).

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
three-arm
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Participant numbers have been set at n=9. Utilising a paper by Levine (1996), results in Table 1 of this paper indicate the average increase in plasma ascorbic acid when dose went from 60 mg to 100 mg was 31.1 uM (SD of the within-person changes 16.4). The average increase in plasma ascorbic acid when dose went from 100 mg to 200 mg was 9.8 uM (SD of the within-person changes 4.6). Using the figures for 60 to 100 mg, to be able to declare these changes significantly different from zero (at p=0.05, one tailed, with 80% power), we would need a sample of 4 participants. To be able to declare a smaller change (15 uM) significant (at p=0.05, one tailed, with 80% power) 9 participants would be needed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
Date of last participant enrolment
Anticipated
3/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment outside Australia
Country [1] 25069 0
New Zealand
State/province [1] 25069 0
Manawatu

Funding & Sponsors
Funding source category [1] 312471 0
Government body
Name [1] 312471 0
Plant and Food Research Institute of NZ
Country [1] 312471 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
Plant and Food Research Institute of NZ
Food Industry Science Centre,
Fitzherbert Science Centre,
23 Batchelar Road, Private Bag 11600
Palmerston North 4410,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314059 0
None
Name [1] 314059 0
Address [1] 314059 0
Country [1] 314059 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311815 0
Health and Disability Ethics Committees
Ethics committee address [1] 311815 0
Ethics committee country [1] 311815 0
New Zealand
Date submitted for ethics approval [1] 311815 0
25/10/2022
Approval date [1] 311815 0
Ethics approval number [1] 311815 0

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

Contacts
Principal investigator
Name 122462 0
Ms Halina Stoklosinski
Address 122462 0
Plant and Food Research Institute of New Zealand
Food Industry Science Centre
Fitzherbert Science Centre
23 Batchelar Road
Palmerston North 4410
Country 122462 0
New Zealand
Phone 122462 0
+64 6 3556229
Fax 122462 0
Email 122462 0
halina.stoklosinski@plantandfood.co.nz
Contact person for public queries
Name 122463 0
Halina Stoklosinski
Address 122463 0
Plant and Food Research Institute of New Zealand
Food Industry Science Centre
Fitzherbert Science Centre
23 Batchelar Road
Palmerston North 4410
Country 122463 0
New Zealand
Phone 122463 0
+64 6 3556229
Fax 122463 0
Email 122463 0
halina.stoklosinski@plantandfood.co.nz
Contact person for scientific queries
Name 122464 0
Halina Stoklosinski
Address 122464 0
Plant and Food Research Institute of New Zealand
Food Industry Science Centre
Fitzherbert Science Centre
23 Batchelar Road
Palmerston North 4410
Country 122464 0
New Zealand
Phone 122464 0
+64 6 3556229
Fax 122464 0
Email 122464 0
halina.stoklosinski@plantandfood.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This work is partly industry funded and publicly disclosing individual participant data will violate our confidentiality agreement to protect the intellectual property generated from this study. Furthermore, ethics guidelines for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study


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
No additional documents have been identified.