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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] 281583 0
Nil
Universal Trial Number (UTN)
U1111-1137-2841
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digestive Health 287864 0
Condition category
Condition code
Inflammatory and Immune System 288227 288227 0 0
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] 286109 0
Treatment: Other
Intervention code [2] 286110 0
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] 288421 0
Significant increase in stool frequency assessed by daily diaries
Timepoint [1] 288421 0
Week 2,6,8,12,14,18,20,24,26
Secondary outcome [1] 300108 0
Clinical secondary endpoints will be significant improvement in stool form (Bristol stool scale)
Timepoint [1] 300108 0
Week 2,6,8,12,14,18,20,24,26
Secondary outcome [2] 300109 0
Improvement in symptoms of Irritable bowel syndrome as assessed by IBS questionnaire
Timepoint [2] 300109 0
Week 2,6,8,12,14,18,20,24,26
Secondary outcome [3] 300110 0
Improvement in quality of life as assesed by QoL questionnaire
Timepoint [3] 300110 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4690 0
New Zealand
State/province [1] 4690 0
Canterbury

Funding & Sponsors
Funding source category [1] 286392 0
Government body
Name [1] 286392 0
Ministry of Business, Innovation and Employment
Address [1] 286392 0
Ministry of Business, Innovation and Employment
Level 3
33 Bowen Street
PO Box 5762
Wellington 6147
Country [1] 286392 0
New Zealand
Funding source category [2] 286393 0
Commercial sector/Industry
Name [2] 286393 0
Stratum Nutrition
Address [2] 286393 0
20 Research Park Drive
Saint Charles, Missouri 63304
Country [2] 286393 0
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] 285178 0
Commercial sector/Industry
Name [1] 285178 0
Anagenix Ltd
Address [1] 285178 0
Level 2
10 Hutt Road
Petone 5012
Wellington
New Zealand
Country [1] 285178 0
New Zealand
Other collaborator category [1] 277200 0
Government body
Name [1] 277200 0
New Zealand Institute of Plant & Food Research
Address [1] 277200 0
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140
Country [1] 277200 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288457 0
Health & Disability Ethics Committee
Ethics committee address [1] 288457 0
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288457 0
New Zealand
Date submitted for ethics approval [1] 288457 0
07/12/2012
Approval date [1] 288457 0
13/01/2013
Ethics approval number [1] 288457 0

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 34979 0
Ms Sarah Eady
Address 34979 0
Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140
Country 34979 0
New Zealand
Phone 34979 0
+64 3 3259671
Fax 34979 0
Email 34979 0
sarah.eady@plantandfood.co.nz
Contact person for public queries
Name 18226 0
Ms Sarah Eady
Address 18226 0
Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140
Country 18226 0
New Zealand
Phone 18226 0
+64 3 3259671
Fax 18226 0
+64 3 3242074
Email 18226 0
sarah.eady@plantandfood.co.nz
Contact person for scientific queries
Name 9154 0
Ms Sarah Eady
Address 9154 0
Plant & Food Research
Canterbury Agricultural and Science Centre
Gerald Street
Lincoln 8140
Country 9154 0
New Zealand
Phone 9154 0
+64 3 3259671
Fax 9154 0
+64 3 3242074
Email 9154 0
sarah.eady@plantandfood.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary