ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612001270808

Ethics application status

Approved

Date submitted

4/12/2012

Date registered

6/12/2012

Date last updated

17/11/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Actazin(TM) for improved digestive health

Scientific title

Amongst indiviudals with mild constipation, does a daily dose of the dietary supplement Actazin(TM) exhibit prebiotic effects which, when compared to a placebo, result in improved general wellbeing, increased stool frequency and beneficial changes in the levels of markers of digestive health?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1137-2841

Trial acronym

Linked study record

Health condition

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

Digestive Health

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomised single blind placebo controlled cross- over trial with participants consuming four different treatments for four weeks, with a 2 week wash out in between each treatment. The treatments are as follows:

1. Actazin(TM) (640mg)/ day
2. Actazin(TM) (2400mg)/ day
3. Actazin(TM) Gold. (2400mg)/ day
4. Placebo

Actazin(TM) is a kiwi fruit based food supplement. Treatments will be delivered in 4 capsules which will be formulated to have the same appearance to maintain blinding to treatments.

- Placebo = 4 x placebo capsules
- 600mg dose = 3 placebo + 1 Actazin(TM) capsule
- 2400mg = 4 Actazin(TM) capsules

The wash out period of two weeks has been chosen to allow sufficient time to return bowel habit to baseline for the parameters we are measuring (stool frequency, wellbeing questionnaires and microbial ecology).

Venous blood samples will be collected at the beginning and end of the study for baseline biochemical analysis. For each day from baseline until the end of the study the participants will record their symptoms including stool frequency, form and associated symptoms in a study diary provided by the investigators.
At the beginning and end of each four week intervention period, participants will be asked to provide a faecal sample and complete a GR-IBS questionnaire as well as an IBS-specific Quality of Life (QoL) questionnaire relating to wellness. Participants will also be asked to complete a 3 day food diary at the beginning and end of the trial to assess individual’s normal dietary intake

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

The supplement will be tested in one cohort with mild constipation (n=30) and one healthy control group (n=20) and will be compared to a placebo treatment. The placebo will be a capsule made from isomalt coloured with food colouring to match the active treatment.

Control group

Placebo

Outcomes

Primary outcome [1]

Significant increase in stool frequency assessed by daily diaries

Timepoint [1]

Week 2,6,8,12,14,18,20,24,26

Secondary outcome [1]

Clinical secondary endpoints will be significant improvement in stool form (Bristol stool scale)

Timepoint [1]

Week 2,6,8,12,14,18,20,24,26

Secondary outcome [2]

Improvement in symptoms of Irritable bowel syndrome as assessed by IBS questionnaire

Timepoint [2]

Week 2,6,8,12,14,18,20,24,26

Secondary outcome [3]

Improvement in quality of life as assesed by QoL questionnaire

Timepoint [3]

Week 2,6,8,12,14,18,20,24,26

Eligibility

Key inclusion criteria

Aged 18 – 55 years (to avoid age groups where possible undiagnosed cancer may start to be an issue).
BMI limits between 19 and 30 k/m2.
Fasting blood glucose under 5.6mmol /L.
Subjects will be required to be willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity pattern throughout the study period. Subjects will be asked to exclude high fibre supplements such as Metamucil (Registered Trademark), Benefibre (Registered Trademark) and Phloe(TM) as well as refraining from eating fresh kiwifruit for the study period.
Participants will also have to avoid overseas travel for the period of the study due to the impact this may have on diet.

Minimum age

18 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Presence of gastrointestinal alarm symptoms (including blood in stools, frequent diarrhoea, unremitting abdominal pain)
Dieters or people who are following vegan, raw food diets or very high fibre diets
Gastroparesis or lactose intolerance
Surgery for weight loss (lapband or gastric bypass)
Pregnant women
Clinically significant renal, hepatic, endocrine, cardiac, pulmonary, pancreatic, neurological, hematologic or biliary disorders
Known allergy or sensitivity to kiwifruit

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)

Subjects will be enrolled by investigators folllowing a face to face interview and given a unique identifying number for labelling all further trial data. This ID number will be provided to an independent biostatisician who will randomise the participants to the treatment schedule

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

simple randomisation by using a randomization table created by a 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 administering 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

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/02/2013

Actual

7/05/2013

Date of last participant enrolment

Anticipated

30/08/2013

Actual

28/08/2013

Date of last data collection

Anticipated

Actual

31/07/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Business, Innovation and Employment

Address [1]

Ministry of Business, Innovation and Employment
Level 3
33 Bowen Street
PO Box 5762
Wellington 6147

Country [1]

New Zealand

Funding source category [2]

Commercial sector/Industry

Name [2]

Stratum Nutrition

Address [2]

20 Research Park Drive
Saint Charles, Missouri 63304

Country [2]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Stratum Nutrition

Address

20 Research Park Drive
Saint Charles, Missouri 63304

Country

New Zealand

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Anagenix Ltd

Address [1]

Level 2
10 Hutt Road
Petone 5012
Wellington
New Zealand

Country [1]

New Zealand

Other collaborator category [1]

Government body

Name [1]

New Zealand Institute of Plant & Food Research

Address [1]

Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health & Disability Ethics Committee

Ethics committee address [1]

1 The Terrace
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

07/12/2012

Approval date [1]

13/01/2013

Ethics approval number [1]

Summary

Brief summary

The consumption of Kiwifruit has been used to reduce constipation and digestive discomfort in New Zealand for several decades and provides a natural, gentle alternative to pharmacological laxative products.  Although clinical trials evaluating  the effectiveness of kiwifruit are limited,  some have shown significant improvements in digestive health (e.g stool frequency, reduced constipation and general overall well being) in both healthy and constipated individuals as well as those suffering from irritable bowel syndrome (IBS).  Actazin(TM) is a dietary supplement/food ingredient from powdered New Zealand kiwifruit which  retains the natural bioactive componenents found in the whole fruit to offer a safe, convenient form of kiwifruit for everyday consumption.  This study aims to examine the effect of daily consumption of Actazin(TM) in healthy individuals and individuals with IBS as part of their everyday diet and lifestyle to determine if the product is effective at improving bowel regularity, digestive discomfort, digestive health and function and gut health.  Participants will be given four different interventions, lasting four weeks each with a two week break in-between. Interventions will consist of Actazin(TM) green standard dose, Actazin(TM) Green high dose, Actazin(TM) gold high dose and placebo.  Participants will be asked to consume the supplements daily at breakfast time and to complete a daily study diary (either online or by hand) to record daily bowel movement and general wellbeing.  Blood samples will be collected at the beginning and end of the study.  Additionally, stool samples will be collected at the beginning and end of each treatment and participants will also be asked to complete two questionnaires relating to bowel health and quality of life at this point (every four week period).

Trial website

Trial related presentations / publications

Ansell, J, Butts C.A., Paturi, G., Eady S.L., Wallace A.J., Hedderley, D., Gearry, R.B. (2015). Efficacy of kiwifruit derived supplements on stool frequency in healthy and functionally constipated individuals: a randomised, double blind trial. Nutrition Research 35:401-408

Public notes

Contacts

Principal investigator

Name

Ms Sarah Eady

Address

Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140

Country

New Zealand

Phone

+64 3 3259671

Fax

sarah.eady@plantandfood.co.nz

Contact person for public queries

Name

Sarah Eady

Address

Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140

Country

New Zealand

Phone

+64 3 3259671

Fax

+64 3 3242074

sarah.eady@plantandfood.co.nz

Contact person for scientific queries

Name

Sarah Eady

Address

Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140

Country

New Zealand

Phone

+64 3 3259671

Fax

+64 3 3242074

sarah.eady@plantandfood.co.nz

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Kiwifruit-derived supplements increase stool frequency in healthy adults: A randomized, double-blind, placebo-controlled study.	2015	https://dx.doi.org/10.1016/j.nutres.2015.04.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically