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Trial registered on ANZCTR


Registration number
ACTRN12618000340235p
Ethics application status
Not yet submitted
Date submitted
27/02/2018
Date registered
6/03/2018
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of SunGold kiwifruit on immune status and inflammatory response
Scientific title
The effect of whole SunGold kiwifruit on immune status and gastrointestinal health in individuals with irritable bowel syndrome complicated by constipation
Secondary ID [1] 294168 0
Nil Known
Universal Trial Number (UTN)
U1111-1209-9283
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome complicated by constipation 306801 0
Condition category
Condition code
Oral and Gastrointestinal 305909 305909 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
A randomised cross over study. A total of 40 individuals will be recruited. 20 participants in the healthy group and 20 participants in the irritable bowel syndrome with constipation group. Participants will be randomised to consume 3 SunGold kiwifruit minus the skin or 3 SunGold kiwifruit plus the skin daily for 4 weeks. The kiwifruit will be in addition to their usual daily diet. They will then have a four week washout before commencing on 4 weeks of the other treatment. The trial will begin with a two week lead in period and finish with a two week washout. Blood samples will be taken for Chem 20 panel, Cytokine (TNFa, IL6) and CRP at baseline as an indication of overall health and to ensure that the eligibility criteria are met. Chem 20 and CRP measurements are not an outcome of the study. Participants will be asked to complete GSRS and Birmingham IBS questionnaire at the beginning of the study and the end of each treatment phase. Stool frequency, form and associated symptoms will be recorded in a daily diary throughout the trial. Three day diet record will be collected at the beginning and end of each treatment phase.

The intervention will be administered by a registered nutritionist with over 30 years experience in science and research. Participants will be seen in individual sessions where treatments will be administered and discussions held around the trial and questionnaires that are required to be filled in during the study. Visits will be for up to 1 hour in duration and will occur at each time point throughout the study (Baseline, two weeks, six weeks, ten weeks, 14 weeks and 16 weeks. The study visits will be held at a clinical trial facility in central Christchurch, NZ. All kiwifruit will be delivered to each participants home/work address on a weekly basis during the duration of the study interventions. Compliance with the study product will be self- monitored by filling in the questions of the the daily diary but participants will be asked at each clinic visit about compliance with the product.
Intervention code [1] 300460 0
Prevention
Intervention code [2] 300461 0
Lifestyle
Intervention code [3] 300462 0
Behaviour
Comparator / control treatment
Healthy participants
Control group
Active

Outcomes
Primary outcome [1] 304948 0
The primary outcome for the trial would be a composite change in the circulating levels of pro-inflammatory cytokines (TNF-a, Il-6) compared to the lead-in period
Cytokine measurement will be in blood plasma samples via ELISA
Timepoint [1] 304948 0
Cytokine measurement will be made at baseline, at the end of intervention 1 (4 weeks post baseline), at then end of washout 1 (8 weeks post baseline), at the end of intervention 2 (12 weeks post baseline) and at the end of the follow up period (16 weeks post baseline). Primary time points will be 4, 8 and 12 weeks.
Primary outcome [2] 304991 0
the second primary outcome would be a change in the circulating levels of anti-inflammatory cytokines (IL-10)
Cytokine levels will be measured via blood plasma samples using ELISA
Timepoint [2] 304991 0
Cytokine measurement will be made at baseline, at the end of intervention 1 (4 weeks post baseline), at then end of washout 1 (8 weeks post baseline), at the end of intervention 2 (12 weeks post baseline) and at the end of the follow up period (16 weeks post baseline).
Primary time points will be 4, 8 and 12 weeks.
Secondary outcome [1] 343680 0
Secondary outcome 1: Quantification of CSBM (complete spontaneous bowel movement), bowel movement frequency, and stool form.
Assessed using the daily bowel habit diary ( a non validated questionnaire designed specifically by the researchers for the study).
This is a composite outcome.
Timepoint [1] 343680 0
CSBM will be measured daily for 16 weeks.
Secondary outcome [2] 343681 0
Secondary outcome 2: changes in digestive symptoms and comfort using the Gastrointestinal Symptom Rating Score and Birmingham IBS score. Both validated questionnaires for assessing gastrointestinal comfort, This is a composite outcome.
Timepoint [2] 343681 0
Measurement will be made at baseline, at the end of intervention 1 (4 weeks post baseline), at then end of washout 1 (8 weeks post baseline), at the end of intervention 2 (12 weeks post baseline) and at the end of the follow up period (16 weeks post baseline).
Secondary outcome [3] 343818 0
Changes in blood glucose control using HBA1C measurement
Timepoint [3] 343818 0
This will be measured at baseline and at the end of the study (16 weeks). Measurement will be assessed through analysis at Canterbury Health Laboratories using verified HBA1C testing techniques
Secondary outcome [4] 343819 0
Changes of habitual daily diet using 3 day diet records
Timepoint [4] 343819 0
Measurements will be made at baseline, at the end of intervention 1 (4 weeks post baseline), at then end of washout 1 (8 weeks post baseline), at the end of intervention 2 (12 weeks post baseline) and at the end of the follow up period (16 weeks post baseline).

Eligibility
Key inclusion criteria
Healthy Participants
a. Adult (18-65 years)
b. BMI 18-35 kgm2
c. Generally healthy
d. Normal bowel habits
IBS-C participants
a. Adult (18-65 years)
b. BMI 18-35 kgm2
c. Meet the criteria for IBS-C as described by the Rome III criteria
Participants with IBS-C (mild). The diagnostic criteria * for Irritable Bowel Syndrome is:
Recurrent abdominal pain or discomfort** at least 3 days per month in the last 3 months associated with 2 or more of the following:
i. Improvement with defecation
ii. Onset associated with a change in frequency of stool
iii. Onset associated with a change in form (appearance of stool)
* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
** Discomfort means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation for subject eligibility.
IBS-C requires meeting the IBS criteria together with – hard or lumpy stools (Bristol Stool Form Scale 1-2) greater than or equal to 25%, and loose or mushy stools greater than or equal to 25% of bowel movements (Bristol Stool Form Scale 6-7).

Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they have any alarm features associated with bowel habit (recent changes in bowel habit (less than 3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD.
Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal cord injury, stroke).
All patients will be screened at recruitment for fasting blood glucose. Those with results greater than or equal to 6.1 mmol/l will not be accepted into the trial as they are at risk of having impaired glucose tolerance, which is an exclusion criteria for the study.
Participants with diagnosed and stable conditions requiring the use of SSRI’s (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for greater than 3 months. Similarly those with stable and controlled diabetes (greater than 3 months) will be permitted to participate.
Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded.
Potential participants with known kiwifruit or latex allergy will be excluded. The reason for excluding latex allergy is because people with this allergy are more likely to have an allergy to food including kiwifruit.
Potential participants using laxatives who are not prepared to stop using the laxatives for the study will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated-measure ANOVAs will be used to examine the treatment effect of SunGold kiwifruit on plasma levels of cytokines.

The study will also detect an increase of 1.5 or more CSBM per week between the 2 treatment arms of the healthy and IBS-C participants.

An initial calculation has been completed using available data. Based on previous studies the standard deviation for the number of CSBM per week is 1.41. In order to detect an increase in CSBM of 1.5 per week in the treatment group compared to the control group, with 90% power and 5% significance, 16 subjects are required to complete the trial. In order to account for an expected 25% dropout, 20 subjects will be recruited for each of two subject populations, or a total of 40 subjects.
Twenty (20) healthy volunteers will be recruited as the healthy control group. The healthy control group will undergo all the same evaluations by the same research team members as the IBS-C group.
All subjects will be requested to maintain their normal dietary habits and physical activity levels throughout the duration of the trial.


Recruitment
Recruitment status
Not yet recruiting
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] 9630 0
New Zealand
State/province [1] 9630 0
Canterbury

Funding & Sponsors
Funding source category [1] 298803 0
Government body
Name [1] 298803 0
The New Zealand Institute for Plant and Food Research Ltd
Address [1] 298803 0
120 Mt Albert Road
Mt Albert
Auckland 1025
Country [1] 298803 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute for Plant and Food Research Ltd
Address
The New Zealand Institute for Plant and Food Research Ltd
120 Mt Albert Road
Mt Albert
Auckland 1025
Country
New Zealand
Secondary sponsor category [1] 297994 0
None
Name [1] 297994 0
Address [1] 297994 0
Country [1] 297994 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299749 0
New Zealand Health & Disabiltiy Committee
Ethics committee address [1] 299749 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299749 0
New Zealand
Date submitted for ethics approval [1] 299749 0
19/03/2018
Approval date [1] 299749 0
Ethics approval number [1] 299749 0

Summary
Brief summary
Our hypothesis is that using the whole fruit (including skin) of SunGold kiwifruit will affect the production of the cytokines IL6 and TNFalpha that are chemicals released into the blood that may increase inflammation that results in unfavorable gastrointestinal symptoms individuals with IBS –C. It is hypothesized that SunGold kiwifruit will help reduce the production of these chemicals and provide greater relief of gastrointestinal symptoms associated with this condition.
A randomised cross over study. A total of 40 individuals will be recruited. 20 participants in the healthy group and 20 participants in the irritable bowel syndrome with constipation group. Participants will be randomised to consume 3 SunGold kiwifruit minus the skin or 3 SunGold kiwifruit plus the skin daily for 4 weeks. They will then have a four week washout before commencing on 4 weeks of the other treatment. The trial will begin with a two week lead in period and finish with a two week washout. Blood samples will be taken for Chem 20 panel, Cytokine (TNFa, IL6) and CRP. Participants will be asked to complete GSRS and Birmingham IBS questionnaire at the beginning of the study and the end of each treatment phase. Stool frequency, form and associated symptoms will be recorded in a daily dairy throughout the trial. Three day diet record will be collected at the beginning and end of each treatment phase. Endpoints will be changes in the levels of pro inflammatory cytokines, changes in stool frequency and improvement in GI wellbeing. Stool form, GSRS and Birmingham IBS symptom questionnaire , HBA1c levels will be secondary endpoints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81450 0
Ms Sarah Eady
Address 81450 0
The New Zealand Institute for Plant and Food Research Ltd
PO Box 4704
Christchurch 8140
Country 81450 0
New Zealand
Phone 81450 0
+64 3 3259671
Fax 81450 0
64 3 325 2074
Email 81450 0
sarah.eady@plantandfood.co.nz
Contact person for public queries
Name 81451 0
Ms Sarah Eady
Address 81451 0
The New Zealand Institute for Plant and Food Research Ltd
PO Box 4704
Christchurch 8140
Country 81451 0
New Zealand
Phone 81451 0
+64 3 3259671
Fax 81451 0
+64 3 325 2074
Email 81451 0
sarah.eady@plantandfood.co.nz
Contact person for scientific queries
Name 81452 0
Ms Sarah Eady
Address 81452 0
The New Zealand Institute for Plant and Food Research Ltd
PO Box 4704
Christchurch 8140
Country 81452 0
New Zealand
Phone 81452 0
+64 3 3259671
Fax 81452 0
+64 3 325 2074
Email 81452 0
sarah.eady@plantandfood.co.nz

No data has been provided for results reporting
Summary results
Not applicable