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Trial registered on ANZCTR


Registration number
ACTRN12613001163796
Ethics application status
Approved
Date submitted
8/10/2013
Date registered
21/10/2013
Date last updated
9/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of kiwifruit extracts on constipation and gut discomfort
Scientific title
A randomised controlled trial evaluating the effects of Kiwifruit extracts on improved bowel movement in men and women
Secondary ID [1] 283375 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel discomfort 290273 0
Constipation – defined as having less than 3 bowel movements per week 290274 0
Condition category
Condition code
Oral and Gastrointestinal 290662 290662 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an encapsulated kiwifruit extract, extracted via a water extraction process from Actinidia deliciosa (from both the skin and flesh). It contains an excipient maltodextrin. The daily dosage will be 1,000mg (2 x 500mg; morning and evening) taken orally with food. This will be taken for a period of 21 days.
A washout period will take place inbetween the intervention (21day) blocks. The washout period will be a minimum of 3 weeks and a maximum of 9 weeks. The washout period will be determined by the participant and when they are able to complete each leg of the study over the study. Capsule count for complience assessment will conducted after 21days. Telephone follow up at 1week and 2week of treatment. Daily assessment of bowel habits by participant self report diary.
Capsules will be labelled A or B (treatment or placebo) by NZ Extracts Ltd.

Arm One - Treatment A or Treatment B
Arm Two - Washout period (break) minimum of 3 weeks and maximum of 9 weeks
Arm Three - Treatment A or Treatment B (crossover)
Intervention code [1] 288100 0
Treatment: Other
Comparator / control treatment
Inert placebo capsules, matched in size and appearance with active capsules. Placebo contains micro crystalline cellulose. These will be taken orally with food. This will be taken for a period of 21 days.
Capsules will be labelled A or B (treatment or placebo) by NZ Extracts Ltd.

Arm One - Treatment A or Treatment B
Arm Two - Washout period (break) minimum of 3 weeks and maximum of 9 weeks
Arm Three - Treatment A or Treatment B (crossover)
Control group
Placebo

Outcomes
Primary outcome [1] 290677 0
Frequency of bowel motion, assessed by bowel habit diary
Timepoint [1] 290677 0
Bowel movements monitored on a daily basis throughout the 3 weeks (21days) of kiwifruit extract supplementation; assessed at baseline and immediately after the completion of the intervention (21 days from start of kiwifruit extract supplementation)
Secondary outcome [1] 305019 0
Ease of passing of stools, consistency and volume of stools; assessed by bowel habit diary entry comparison to Bristol Stool Form Chart.
Timepoint [1] 305019 0
Bowel movements monitored on a daily basis throughout the 3 weeks (21days) of kiwifruit extract supplementation; assessed at baseline and immediately after the completion of the intervention (21 days from start of kiwifruit extract supplementation).
Secondary outcome [2] 305039 0
Microbiota community, extract DNA for 16S pyrosequencing of microbiome
Timepoint [2] 305039 0
5g faecal sub-sample collected at baseline (day0) and collected at the end of intervention (day21).
Secondary outcome [3] 305040 0
QSRS (gastrointestinal symptom rating scale)
Timepoint [3] 305040 0
Assessment form collected at day0 and day21 of intervention period.

Eligibility
Key inclusion criteria
Self reported as healthy
Male/Female
20-65 yrs
Suffer constipation and bowel discomfort
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant GI disease including IBD, Crohn’s disease, ulcerative colitis, coeliac disease, or inflammatory or malabsorptive condition

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation, a completely balanced design of treatment A and treatment B (generated with excel software)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis on bowel habit diary to determine increased frequency. Further statistical analysis of improvment to bowel motion including ease, consistency and volume of passing stools.

We will use estimated power tests for change in number of bowel habits over 3/4 weeks, using a 2 treatment, placebo controlled, cross-over design; based on between group and within group variance and modelling published data from Rush et al 2002, Chan et al 2007, Chang et al 2010; 95% significance with 80% power; ITT analyses of outcomes; estimated to require between 30 to 40 participants to be randomised.

Recruitment
Recruitment status
Completed
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] 5490 0
New Zealand
State/province [1] 5490 0
Auckland

Funding & Sponsors
Funding source category [1] 288100 0
Commercial sector/Industry
Name [1] 288100 0
New Zealand Extracts Ltd
Address [1] 288100 0
16 Liverpool St, Riverlands, Blenheim 7274
Country [1] 288100 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Extracts Ltd
Address
New Zealand Extracts Ltd
16 Liverpool St, Riverlands, Blenheim 7274
Country
New Zealand
Secondary sponsor category [1] 286820 0
None
Name [1] 286820 0
none
Address [1] 286820 0
none
Country [1] 286820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290023 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 290023 0
Health and Disability Ethics Committee, Ministry of Health, C/- MEDSAFE, Level 6, Deloitte House, 10 Brandon Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 290023 0
New Zealand
Date submitted for ethics approval [1] 290023 0
Approval date [1] 290023 0
01/10/2013
Ethics approval number [1] 290023 0
13/NTB/132

Summary
Brief summary
The aim of this study is to determine the effect of encapsulated kiwifruit extract on bowel habits, gut comfort, change in faecal microbiota, and quality of life in men and women with self-reported constipation, but otherwise healthy.
This will be a 2 treatment, double blind, randomised, crossover trial, comparing the active treatment, NZ Extracts encapsulated kiwifruit extract, with a matched placebo. Each treatment will be administered for a 3 week period, separated by a minimum 3 week washout period. The total trial length will be between 9-15 weeks; allowing for a maximum washout period of 9 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43550 0
Prof Sally Poppitt
Address 43550 0
Human Nutrition Unit
18 Carrick Place
Mt Eden, Auckland 1024
Country 43550 0
New Zealand
Phone 43550 0
+64 9 630 5160
Fax 43550 0
Email 43550 0
s.poppitt@auckland.ac.nz
Contact person for public queries
Name 43551 0
Miss Sophie Kindleysides
Address 43551 0
Human Nutrition Unit
18 Carrick Place
Mt Eden, Auckland 1024
Country 43551 0
New Zealand
Phone 43551 0
+64 9 630 1162
Fax 43551 0
Email 43551 0
s.kindleysides@auckland.ac.nz
Contact person for scientific queries
Name 43552 0
Prof Sally Poppitt
Address 43552 0
Human Nutrition Unit
18 Carrick Place
Mt Eden, Auckland 1024
Country 43552 0
New Zealand
Phone 43552 0
+64 9 630 5160
Fax 43552 0
Email 43552 0
s.poppitt@auckland.ac.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