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Trial registered on ANZCTR


Registration number
ACTRN12621000109808p
Ethics application status
Not yet submitted
Date submitted
2/12/2020
Date registered
3/02/2021
Date last updated
3/02/2021
Date data sharing statement initially provided
3/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Actazin on bowel movements in healthy but constipated New Zealanders
Scientific title
Impact of 600 mg Actazin® on complete spontaneous bowel movements and Bristol stool scores in healthy but constipated individuals in New Zealand
Secondary ID [1] 302888 0
None
Universal Trial Number (UTN)
U1111-1262-1865
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 320372 0
Condition category
Condition code
Metabolic and Endocrine 317892 317892 0 0
Other metabolic disorders
Oral and Gastrointestinal 318271 318271 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is a 28 day lead-in period where participants will consume 1 x inactive placebo (maltodextrin) 600 mg capsule prior to the first intervention period.
Then participants will enter their first randomly allocated intervention period, comprising either 1 x Actazin 600 mg capsule intervention product or 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 days.
The first intervention phase will be followed by a 14 day washout phase in between intervention periods, where they will consume 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal.
Finally, participants will enter their second randomly allocated intervention period, comprising either 1 x Actazin 600 mg capsule intervention product or 1 x inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 days.
Compliance will be assessed by the participants returning all capsule containers in an addressed, postage-paid courier bag for a capsule usage count.
Intervention code [1] 319219 0
Treatment: Other
Comparator / control treatment
Inactive placebo (maltodextrin) 600 mg capsule, once daily at least an hour before and after a meal, for 28 day lead-in period, one of the two 28 day intervention phases, and the 14 day in-between washout phase
Control group
Placebo

Outcomes
Primary outcome [1] 325906 0
Self-assessed change from baseline (day 0) in bowel habits using a bowel habits diary, completed by accessing a link (sent electronically to participants daily) to a web form to capture their results.
Timepoint [1] 325906 0
Daily, from end of day 0 to end of 28 day of each intervention phase
Primary outcome [2] 325907 0
Self-assessed change from baseline (day 0) in stool form using the Bristol Stool Score chart, completed by accessing a link (sent electronically to participants daily) to a web form to capture their results.
Timepoint [2] 325907 0
Daily, from end of day 0 to end of 28 day of each intervention phase
Secondary outcome [1] 389476 0
Change from baseline (day 0) in quality of life, assessed using PAC-QoL questionnaire, completed by accessing a link (sent electronically to participants at day 0 and day 28 of each intervention phase) to a web form to capture their results.
Timepoint [1] 389476 0
At end of day 0 and end of 28 day of each intervention phase
Secondary outcome [2] 389477 0
Change from baseline (day 0) in constipation symptoms, assessed using PAC-SYM questionnaire, completed by accessing a link (sent electronically to participants at day 0 and day 28 of each intervention phase) to a web form to capture their results.
Timepoint [2] 389477 0
At end of day 0 and end of 28 day of each intervention phase

Eligibility
Key inclusion criteria
Participants must meet all the following criteria:
a. They are an adult aged 18-65
b. They have functional constipation assessed as equal to or greater than two of the following:
i. Straining (for more than 25% of defecations)
ii. Lumpy of hard stools scoring 1 or 2 on Bristol Stool Score (for greater than 25% of defecations)
iii. Sensation of incomplete evacuations (for greater than 25% of defecations)
iv. Sensation of anorectal obstruction/blockage (for greater than 25% of defecations)
v. Manual manoeuvres to facilitate defecation, e.g. digital evacuation, pelvic floor support (for greater than 25% of defecations)
vi. Less than 3 spontaneous bowel movements per week.
c. They are on stable medication for at least 4 weeks prior to recruitment, and unlikely to change medication during the course of this study
d. They are not currently participating in another clinical interventional study
e. They are not currently pregnant or lactating.
f. They will provide written informed consent
g. They agree to avoid eating kiwifruit or other kiwifruit-derived products for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with at least one of the following criteria will be excluded:
a. Current or prior (previous six months) antibiotic treatment
b. Current or prior eating disorder (e.g. anorexia nervosa, bulimia) that would interfere with consumption and/or absorption of the investigational product
c. Current viral hepatitis (type A, B or C), liver cirrhosis, chronic kidney disease, heart failure, thyroid disease or cancer.
d. Food allergy or intolerance that would compromise compliance with the study protocol, including kiwifruit, or latex allergy
e. Prior gastrointestinal surgery (e.g. cholecystectomy, gastric lap band or gastric bypass), not including appendicitis or caesarean section.
f. Gastrointestinal alarm symptoms including rectal bleeding, weight loss, blood in stools, frequent diarrhoea, and unremitting abdominal pain, and major diseases of the gastrointestinal tract (such as IBS, Crohn’s disease, celiac disease, ulcerative colitis, malignant tumour of the colon, etc.), pulmonary or endocrine systems, or other GI abnormalities.

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)
Central randomization by software
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

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assumed for the sample size estimates were:
1. Two-sided testing with alpha equal to 0.05.
2. 80% Power to detect a significant difference between groups.
3. 20% attrition rate from enrolment to final post-baseline measurement.
4. Primary outcome is average weekly bowel movement.
5. According to a previous parallel study (Udani and Bloom 2013) on effects of kiwifruit-derived products on stool frequency, standard deviation (SD) for the average weekly number of complete spontaneous bowel movements is determined to be 2 times/week.
Based on a pooled SD of 2.10 CSBMs/week obtained at Week 4 of a previous unpublished study calculated during an interim analysis, if the weekly number of complete spontaneous bowel movements in an investigational product group is 1.6 times/week different than in the placebo group, 44 will be required to have an 80% power with an overall alpha of 0.05 and 20% attrition rate. Erring on the side of caution, we shall aim to enrol 50 participants.
Primary outcome data will be analysed by repeated measures ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 23241 0
New Zealand
State/province [1] 23241 0
all

Funding & Sponsors
Funding source category [1] 307307 0
Commercial sector/Industry
Name [1] 307307 0
Anagenix Ltd
Country [1] 307307 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Anagenix Ltd
Address
Level 1, 272 Parnell Road,
Parnell, Auckland 1052
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307994 0
None
Name [1] 307994 0
Address [1] 307994 0
Country [1] 307994 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307402 0
New Zealand Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 307402 0
Ministry of Health
Unisys Building,
650 Great South Road, Penrose, Auckland 1051
New Zealand
Ethics committee country [1] 307402 0
New Zealand
Date submitted for ethics approval [1] 307402 0
12/02/2021
Approval date [1] 307402 0
Ethics approval number [1] 307402 0

Summary
Brief summary
The aims of this study are to determine whether a 4-week, daily supplementation of a New Zealand kiwifruit supplement product (Actazin®) can change bowel habits in free-living adults with functional constipation over baseline (day 0) values.

It is a randomised crossover placebo-controlled double-blind study.
The study duration is 14 weeks; 4-week lead-in period for acclimatisation and baseline measurements, followed by a 4-week intervention period, a 2-week washout period, followed by another 4-week intervention period.

Participants will be recruited from social media advertising (e.g. Facebook). The aims of the study and investigational product will be described, along with descriptions of the questionnaires and demographic data sought. It is hoped that people with functional constipation but otherwise healthy will volunteer to participate. Following confirmation of participation, receipt of informed consent, self-assessed meeting of the inclusion/exclusion criteria and appropriateness of volunteered data, participants will be sent to consume daily, for 4 weeks, a capsule of placebo containing maltodextrin to acclimatise themselves to the study and its questionnaires. After this 4 week lead-in period they will be send for the first 4-week intervention period either a capsule of 600 mg Actazin on an empty stomach 1 h before a meal, or placebo containing coloured, flavoured maltodextrin, and asked to continue to volunteer appropriate questionnaire reports on their bowel habits and stool form. After 4 weeks, participants will have a 2 week washout period on placebo, followed by another 4-week intervention period where they will be sent to consume daily , either a capsule of 600 mg Actazin on an empty stomach 1 h before a meal or placebo containing coloured, flavoured maltodextrin, and continue to volunteer appropriate questionnaire reports on their bowel habits and stool form.

At baseline (day 0) and endpoint (day 28) of each intervention, participants will complete questionnaires to assess their quality of life and constipation symptoms.

No biological samples will be taken from participants expressly for the purposes of this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107106 0
Dr Doug Rosendale
Address 107106 0
Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country 107106 0
New Zealand
Phone 107106 0
+64 9 520 0831
Fax 107106 0
Email 107106 0
[email protected]
Contact person for public queries
Name 107107 0
Doug Rosendale
Address 107107 0
Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country 107107 0
New Zealand
Phone 107107 0
+64 9 520 0831
Fax 107107 0
Email 107107 0
[email protected]
Contact person for scientific queries
Name 107108 0
Doug Rosendale
Address 107108 0
Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country 107108 0
New Zealand
Phone 107108 0
+64 9 520 0831
Fax 107108 0
Email 107108 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
To respect participant confidentiality, particularly any Maori participants who may be recruited, as they must approve any usage of their data, as per New Zealand Ministry of health guidelines and the Treaty of Waitangi.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10295Study protocol  [email protected]
10296Informed consent form  [email protected]
10297Ethical approval  [email protected]
10298Clinical study report  [email protected]



Results publications and other study-related documents

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