ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1262-1865

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

constipation

Condition category

Condition code

Metabolic and Endocrine

Other metabolic disorders

Oral and Gastrointestinal

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]

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]

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]

Daily, from end of day 0 to end of 28 day of each intervention phase

Primary outcome [2]

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]

Daily, from end of day 0 to end of 28 day of each intervention phase

Secondary outcome [1]

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]

At end of day 0 and end of 28 day of each intervention phase

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

all

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Anagenix Ltd

Address [1]

Level 1, 272 Parnell Road
Parnell, Auckland 1052
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

New Zealand Health and Disability Ethics Committee (HDEC)

Ethics committee address [1]

Ministry of Health
Unisys Building,
650 Great South Road, Penrose, Auckland 1051
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

12/02/2021

Approval date [1]

Ethics approval number [1]

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

Dr Doug Rosendale

Address

Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand

Country

New Zealand

Phone

+64 9 520 0831

Fax

doug.rosendale@anagenix.com

Contact person for public queries

Name

Doug Rosendale

Address

Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand

Country

New Zealand

Phone

+64 9 520 0831

Fax

doug.rosendale@anagenix.com

Contact person for scientific queries

Name

Doug Rosendale

Address

Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand

Country

New Zealand

Phone

+64 9 520 0831

Fax

doug.rosendale@anagenix.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
10295	Study protocol	doug.rosendale@anagenix.com
10296	Informed consent form	doug.rosendale@anagenix.com
10297	Ethical approval	doug.rosendale@anagenix.com
10298	Clinical study report	doug.rosendale@anagenix.com

Results publications and other study-related documents

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No additional documents have been identified.

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