Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000899741
Ethics application status
Approved
Date submitted
28/04/2022
Date registered
23/06/2022
Date last updated
28/07/2023
Date data sharing statement initially provided
23/06/2022
Date results information initially provided
28/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
'Monty's Surprise' apple Bioavailability study
Scientific title
Evaluation of bioavailability and antioxidant effects of phytochemicals presented in 'Monty's Surprise' apple puree in healthy adults.
Secondary ID [1] 307022 0
none
Universal Trial Number (UTN)
U1111-1277-8157
Trial acronym
ABS
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Cancer 326150 0
Condition category
Condition code
Diet and Nutrition 323468 323468 0 0
Other diet and nutrition disorders
Cancer 323582 323582 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted in Te Ohu Health unit at Massey University, Palmerston North. This study will be performed as a single-blind, randomised cross over study. One group (Group A) of the participants (6 participants) will receive placebo meal first and second group (Group B) (6 participants) will receive study meal first. Each study visit will last 8 hours.There will be one week wash out period between two visits.
All the study meals will be prepared in the product development lab, Massey University, Palmerston North. The study meal is MS apple puree (500g). The apple puree will be provided as a breakfast. Macronutrient matched placebo will be prepared from water and sugars presented in apple puree.
The trial will consist of a screening visit and 2 study visits (visit 1 and visit 2). The night before the study visits, participants will be asked to fast from 10 pm (overnight) till the start of the study (8 am). At the study visit a cannula will be inserted into their forearm through which the blood samples will be collected by by trained and approved individual.
Intervention code [1] 323468 0
Prevention
Comparator / control treatment
Apple puree macronutrient matched placebo will be prepared from corn starch.
Control group
Placebo

Outcomes
Primary outcome [1] 331208 0
Plasma metabolites
Timepoint [1] 331208 0
0,1,2,4,6,8 post study meal consumption
Primary outcome [2] 331209 0
Antioxidant activity of phytochemicals presented in plasma after apple puree consumption.
Timepoint [2] 331209 0
0,1,2,4,6,8 hours post study meal consumption
Secondary outcome [1] 409197 0
Glucose levels evaluated from plasma at 0, 15, 30 minutes and 1,2 hours after apple puree consumption.
Timepoint [1] 409197 0
0, 15 and 30 minutes, 1, 2 hours post study meal consumption

Eligibility
Key inclusion criteria
• non-smokers
• age 18-45
• healthy with normal body mass index (BMI from 18 kg/m2 to 25 kg/m2)
• no more than 10 hours of vigorous exercise per week
• able to consume apple
• for women before menopause
• able to not drink coffee/tea for 24 hours
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• taking any medication
• history of digestive disorder or chronic disease
• suffering from illnesses like HIV/Aids or inflammatory bowel disease
• dairy, eggs and gluten allergy/intolerance
• pregnancy or breast feeding
• recently donated blood or have fear from blood taking or needles

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
The study size was calculated using G power. The effect size needed for the G power calculations was calculated by subtracting the means and dividing the result by the pooled standard deviation of total phenolic content in plasma samples after apple juice consumption and control plasma samples after overnight fast based on the earlier published study. Study group size was calculated using a priori, t-test, difference between two means given effect size mentioned above, level of significance 0.05 and providing 80% power. Based on the result the minimal group size for this study is 10 participants, however considering 10% drop-out rate, we will recruit group of twelve participants (n=12) consisting of six males and six females.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2022
Actual
27/07/2022
Date of last participant enrolment
Anticipated
26/07/2022
Actual
28/10/2022
Date of last data collection
Anticipated
30/10/2022
Actual
30/11/2022
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 24740 0
New Zealand
State/province [1] 24740 0
Manawatu

Funding & Sponsors
Funding source category [1] 311332 0
University
Name [1] 311332 0
Massey University
Country [1] 311332 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University, Private Bag 11 222
Palmerston North, 4442, New Zealand
Country
New Zealand
Secondary sponsor category [1] 312708 0
Other Collaborative groups
Name [1] 312708 0
Heritage Food Crops Research Trust
Address [1] 312708 0
Heritage Food Crops Research Trust
126A Springvale Road
Whanganui 4501
New Zealand
Country [1] 312708 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310831 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310831 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 310831 0
New Zealand
Date submitted for ethics approval [1] 310831 0
16/05/2022
Approval date [1] 310831 0
14/07/2022
Ethics approval number [1] 310831 0
2022 EXP 12268

Summary
Brief summary
Recent studies have suggested that apple consumption may reduce the risk of several types of cancer, due to their antioxidant and anti-inflammatory effects. However, the main phytochemicals present and subsequent antioxidant effects after apple consumption have not yet been fully characterised. Therefore, the purpose of this study is to evaluate the bioavailability of apple phytochemicals and the antioxidant effects of these phytochemicals in the plasma of healthy volunteers.

Who is it for?
You may be eligible for this study if you are aged between 18-45 years, a non-smoker, are a healthy weight, participate in no more than 10 hours of vigorous exercise per week, are able to consume apple, are pre-menopausal, and are able to not drink coffee or tea for 24 hours.

Study details
Participants will be randomised (i.e. allocated by chance) to receive either 500g of 'Monty's Surprise' apple puree, or a macronutrient-matched placebo puree. The puree will be consumed at 8am at the study site, following an overnight fast from 10pm the previous night. Participants will remain at the study site for a further 8 hours, where a cannula will be inserted into their forearm for collection of blood samples during this period. These blood samples will be used to assess the metabolites present in plasma, the antioxidant activity of phytochemicals, and glucose levels after consumption of the puree.

It is hoped that this study will identify main metabolites in the plasma after apple puree consumption, which will inform future cell culture studies. Moreoevr, this study may show that apple puree consumption increases antioxidant activity and reduces blood glucose levels, which may help to provide evidence for the mechanisms by which apple consumption reduces cancer risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119018 0
Miss Linda Nezbedova
Address 119018 0
School of Food and Advanced Technology, Massey University, Private Bag 11 222, 4442 Palmerston North
Country 119018 0
New Zealand
Phone 119018 0
+64 02041925283
Fax 119018 0
Email 119018 0
l.nezbedova1@massey.ac.nz
Contact person for public queries
Name 119019 0
Miss Linda Nezbedova
Address 119019 0
School of Food and Advanced Technology, Massey University, Private Bag 11 222, 4442 Palmerston North
Country 119019 0
New Zealand
Phone 119019 0
+64 02041925283
Fax 119019 0
Email 119019 0
l.nezbedova1@massey.ac.nz
Contact person for scientific queries
Name 119020 0
Miss Linda Nezbedova
Address 119020 0
School of Food and Advanced Technology, Massey University, Private Bag 11 222, 4442 Palmerston North
Country 119020 0
New Zealand
Phone 119020 0
+64 02041925283
Fax 119020 0
Email 119020 0
l.nezbedova1@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15889Study protocol  l.nezbedova1@massey.ac.nz
15890Informed consent form  l.nezbedova1@massey.ac.nz
15891Ethical approval  l.nezbedova1@massey.ac.nz



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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