Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000594729
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
21/04/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of fruit organic acids on glycaemia and laxation
Scientific title
Fruit organic acid effects on glycaemia and laxation in healthy adults - a randomised, repeated measures, human intervention study.
Secondary ID [1] 306850 0
Nil known
Universal Trial Number (UTN)
U1111-1276-8367
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 325941 0
Metabolic health 325942 0
Condition category
Condition code
Metabolic and Endocrine 323253 323253 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1 - Glycaemia :
The participants will be required to attend the clinic on 3 study days, and consume one of the test meals at each visit.

The test meals will be:

1. Water (control) + WeetBix™
2. Fruit organic acid solution at pH 3.4 + WeetBix™
3. Fruit organic acid solution neutralised (pH 7.0) + WeetBix™

In all meals the volume of water or fruit acid solution will be 250 ml (1 standard cup) and the quantity of WeetBix will be 60 g (4 biscuits). An additional 200 ml of water will be consumed with all diets.
Adherence of the intervention will be by the researchers directly observing the participants during the 3 hours for each session. There will be a wash-out period of 48 hours between each treatment.

Part 2 - Laxation:
The laxation study will follow the glycaemia study after a washout period of 3 days. There will be two treatments:

1. Water (control)
2. Organic acid solution at pH 3.4 (the same pH as kiwifruit flesh)

The order in which the participants will take the treatments will be determined by randomising. After the washout period the participant will go on to the first treatment for 5 days, have a three day break, and then take the second treatment for 5 days.

The frequency of administration of the treatment will be once daily in the morning with breakfast or just before breakfast for 5 days. Adherence to the intervention will be checklist that the participants will have to complete each day.
Intervention code [1] 323314 0
Prevention
Intervention code [2] 323315 0
Lifestyle
Comparator / control treatment
Control is water
Control group
Active

Outcomes
Primary outcome [1] 330997 0
Blood glucose as assessed by finger-prick blood test. This outcome will be assessed in Part 1 of the study only.
Timepoint [1] 330997 0
Blood glucose testing will be timed from the start of food consumption. It will be done by finger prick sampling of capillary blood at 15 min intervals in the first hour, and then at 30 min intervals until 180 min has elapsed. Samples will be collected at 0 (baseline x 2), 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Blood glucose will be measured immediately using a HemoCue® blood glucose meter.
Primary outcome [2] 330998 0
Measure changes in insulin. This outcome will be assessed in Part 1 of the study only.
Timepoint [2] 330998 0
Capillary blood sample will be drawn into a Z gel serum Microvette® microtube designed for capillary blood collection, centrifuged and stored at -80°C for later analysis of insulin.
Timepoints: 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes are relative to the participants post-meal consumption.
Primary outcome [3] 330999 0
Timing of defaecation, frequency and estimated volume of stool, and form of stool . This is composite.
The participants will be asked to record the time of bowel movements, stool form scored using the Bristol Stool Scale, stool volume estimated by comparison with provided reference volumes, in a 24 h Bowel Activity Diary (BAD) questionnaire constructed for the trial.
This assessment is for Part 2 only.
Timepoint [3] 330999 0
The outcomes will be assessed continuously for 5 days for each treatment
Secondary outcome [1] 408442 0
Changes in satiety will also be measured using 'Visual Analogue Scale'.
This outcome will be assessed in Part 1 of the study only.
Timepoint [1] 408442 0
At time 0, 15, 60, 120 and 180 min, post-test meal consumption, appetite will be assessed using a Visual Analogue Scale (VAS). VAS is used for self-reporting appetite in healthy adult.
Secondary outcome [2] 408445 0
Changes in feeling of gut comfort will be assessed in Part 2 only of the study.
Assessment of gut comfort will be daily for 5 days for each treatment by AstraZeneca's validated questionnaire.
Timepoint [2] 408445 0

There are two treatments in Part 2 of this study (laxation).
Each treatment will be consumed daily for five days.

Eligibility
Key inclusion criteria
• healthy individual of any gender
• aged 18-50 years
• no known hypersensitivity or intolerance to wheat
• do not suffer from gastritis
• absence of pathological bowel disorder
• willing to fast from 9.00 pm the evening before a test for the glycaemia study
• give written consent and agree to comply with the conditions of the study
• willing to consume no food other than the breakfast supplied and water until the last blood sample on the trial days of the glycaemia study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Intolerant to acidic foods
• gut condition such as irritable bowel syndrome, peptic ulcers or are taking laxative.
• suffer from diabetes or prediabetes
• have a fasting blood glucose of greater than 5.6 mmol/L
• have glycosylated haemoglobin (HbA1c) of greater than 40 mmol/mol

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)
Participants who pass the screening procedure will be allocated the study trial numbers (de-identified). Each participant will receive all treatments in random order. Randomization of the samples and treatments will be completed by a statistician at Plant & Food Research using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the diets and treatments for each participant (n=16) will be determined by computer randomisation of numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Groups will be compared in terms of incremental area under the curve for blood glucose response, insulin, and satiety by comparison of treatments.
Groups will be compared in terms frequency of defaecation and volume of defaecation by comparison of treatments.


A registered statistician at Plant and Food Research will conduct the statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2022
Actual
25/05/2022
Date of last participant enrolment
Anticipated
10/06/2022
Actual
22/09/2022
Date of last data collection
Anticipated
29/07/2022
Actual
19/12/2022
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 24707 0
New Zealand
State/province [1] 24707 0
Manawatu-Wanganui

Funding & Sponsors
Funding source category [1] 311174 0
Government body
Name [1] 311174 0
The New Zealand Institute for Plant and Food Research
Country [1] 311174 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute for Plant and Food Research
Address
Batchelar Road,
Food Science Centre,
Palmerston North, 4442
Country
New Zealand
Secondary sponsor category [1] 312534 0
None
Name [1] 312534 0
None
Address [1] 312534 0
Not applicable
Country [1] 312534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310705 0
The Central Health and Disability Ethics Committee
Ethics committee address [1] 310705 0
Ethics committee country [1] 310705 0
New Zealand
Date submitted for ethics approval [1] 310705 0
24/03/2022
Approval date [1] 310705 0
20/04/2022
Ethics approval number [1] 310705 0
2022 EXP 12264

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

Contacts
Principal investigator
Name 118578 0
Dr Suman Mishra
Address 118578 0
Plant and Food Research
Food Industry Science Centre
Private Bag 11600
Palmerston North 4442
Country 118578 0
New Zealand
Phone 118578 0
+64 6 3556146
Fax 118578 0
Email 118578 0
[email protected]
Contact person for public queries
Name 118579 0
Suman Mishra
Address 118579 0
Plant and Food Research
Food Industry Science Centre
Private Bag 11600
Palmerston North 4442
New Zealand
Country 118579 0
New Zealand
Phone 118579 0
+64 6 3556146
Fax 118579 0
Email 118579 0
[email protected]
Contact person for scientific queries
Name 118580 0
Suman Mishra
Address 118580 0
Plant and Food Research
Food Industry Science Centre
Private Bag 11600
Palmerston North 4442
Country 118580 0
New Zealand
Phone 118580 0
+64 6 3556146
Fax 118580 0
Email 118580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be shared. The sum of all the data will be used in analyses and used in publications


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.