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Trial registered on ANZCTR


Registration number
ACTRN12618000875202
Ethics application status
Approved
Date submitted
8/05/2018
Date registered
23/05/2018
Date last updated
31/08/2023
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of ActiPhen™ on gastrointestinal tract function in otherwise healthy adults. A randomised double blind placebo-controlled study.
Scientific title
Efficacy of ActiPhen™ on gastrointestinal tract function in otherwise healthy adults. A randomised double blind placebo-controlled study.
Secondary ID [1] 294180 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WAIKFG-18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal tract function 306812 0
Condition category
Condition code
Oral and Gastrointestinal 305920 305920 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 90 adult male and female participants aged over 18 years will be recruited from databases and public media outlets.

Participants will take the allocated product daily for 6 weeks attend the study site at week 3 and week 6 for progress assessments. Consenting participants will undergo a health assessment including lifestyle, current medications, weight and height assessment, GIT function (questionnaire), quality of life (fatigue) and medical history. Blood lutein, serotonin and zonulin concentration and MPOD will also be measured. As Kiwi fruit is a known source of Lutein, both plasma lutein and macula pigment density will be measured to assess if ActiPhen™ can supplement lutein concentration in the plasma and in turn increase macular pigment in the eye.

Participants will be allocated 1 of 3 products in capsule form and the capsules are to be taken orally at breakfast time with food and 250mL water. The 3 products are as per the below:

1. ActiPhen™ 1000mg dose (over 6 capsules)
2. ActiPhen™ 3000mg dose (over 6 capsules)
3. Placebo – 4300mg maltodextrin (over 6 capsules)
Intervention code [1] 300471 0
Treatment: Other
Comparator / control treatment
Placebo capsules x 6 daily

The placebo will be filled with maltodextrin and are vegetarian microcrystalline hard shell capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 304951 0
Change in gastrointestinal tract function as assessed by stool frequency via a daily diary
Timepoint [1] 304951 0
Baseline, week 3 and 6 (end point)
Secondary outcome [1] 343704 0
Change in gastrointestinal function as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [1] 343704 0
Baseline, week 3 and week 6 (end point)
Secondary outcome [2] 343705 0
Change in gastrointestinal function as assessed by the Irritable bowel syndrome symptom scoring system (IBS-SSS)
Timepoint [2] 343705 0
Baseline, week 3 and week 6 (end point)
Secondary outcome [3] 343707 0
Stool consistency as assessed by the Bristol stool chart
Timepoint [3] 343707 0
Baseline, week 3 and 6 (end point)
Secondary outcome [4] 343708 0
Change in gut permeability as assessed by plasma zonulin serum assay
Timepoint [4] 343708 0
Baseline and week 6 (end point)
Secondary outcome [5] 343709 0
Change in quality of life as assessed by SF-36 questionnaire
Timepoint [5] 343709 0
Baseline, week 3 and 6 (end point)
Secondary outcome [6] 343710 0
Change in plasma lutein as assessed by serum assay
Timepoint [6] 343710 0
Baseline and week 6
Secondary outcome [7] 343711 0
Change in MPOD score as assessed by MPS II Macular Pigment Screener
Timepoint [7] 343711 0
Baseline and week 6
Secondary outcome [8] 343712 0
Change in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [8] 343712 0
Baseline, week 3 and 6 (end point)
Secondary outcome [9] 343713 0
Change in fatigue as assessed by the SF-36 questionnaire
Timepoint [9] 343713 0
Baseline, week 3 and 6 (end point)
Secondary outcome [10] 343714 0
Gastrointestinal tolerance as assessed by the Gastrointestinal tract tolerance questionnaire
Timepoint [10] 343714 0
Baseline, week 3 and 6 (end point)
Secondary outcome [11] 343715 0
Dietary intake as assessed by a diet diary
Timepoint [11] 343715 0
Baseline, week 3 and 6 (end point)
Secondary outcome [12] 343716 0
Body mass index as assessed by digital scale weight measure and stadiometer for height
Timepoint [12] 343716 0
Baseline and week 6 (end point)
Secondary outcome [13] 343717 0
Heart rate as assessed by a digital blood pressure and heart rate monitor
Timepoint [13] 343717 0
Baseline and week 6 (end point)
Secondary outcome [14] 343718 0
Blood pressure as assessed by a digital blood pressure monitor
Timepoint [14] 343718 0
Baseline and week 6 (end point)
Secondary outcome [15] 377438 0
Change in plasma serotonin as assessed by serum assay
Timepoint [15] 377438 0
Baseline and Week 6
Secondary outcome [16] 426245 0
Change in gastrointestinal tract function as measured by The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL)
Timepoint [16] 426245 0
Baseline, Week 3 and 6 (endpoint)

Eligibility
Key inclusion criteria
- Males and females aged over 18 years
- Females using a prescribed form of birth control (e.g. oral contraceptive)
- Experiencing three or more of the following symptoms of gastrointestinal discomfort including bloating, flatulence, diarrhoea, constipation, reflux, heart burn, abdominal pain/discomfort experienced at least 3 days in the last month
- Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2 month period of self-reported dietary stability.
- Agree to not change current diet or exercise regime during entire study period
- Agree to not use any other dietary supplements or digestive enzymes during the study period
- Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland
function Malignancy)
- People with a past or current history of inflammatory bowel disease or gastrointestinal tract
surgery
- Pregnant or breastfeeding mothers
- Malignancy or treatment for malignancy within the previous 2 years
- Receiving/ prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other
anticoagulation therapy including low dose aspirin
- Active smokers, nicotine, alcohol, drug abuse
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Any history of kiwi fruit allergy
- Those suffering from insomnia or have night-shift employment and unable to have a normal
night’s sleep
- People suffering any neurological disorders such as MS
- Any condition which in the opinion of the investigator makes the participant unsuitable for
inclusion (including hypercholesterolemia)
- Participants who have participated in any other clinical trial during the past 3 months
- Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
- History of infection in the month prior to the study or taking antibiotic therapy
- Hydration therapy during study period

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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2018
Actual
15/11/2018
Date of last participant enrolment
Anticipated
Actual
8/11/2019
Date of last data collection
Anticipated
Actual
19/12/2019
Sample size
Target
90
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298812 0
Commercial sector/Industry
Name [1] 298812 0
Waitaki Biosciences
Country [1] 298812 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 298006 0
Commercial sector/Industry
Name [1] 298006 0
Waitaki Biosciences
Address [1] 298006 0
Waitaki Biosciences
3 Desi Place, Hillsborough, 8022, Christchurch, New Zealand
Country [1] 298006 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299759 0
Bellberry Limited
Ethics committee address [1] 299759 0
Ethics committee country [1] 299759 0
Australia
Date submitted for ethics approval [1] 299759 0
06/02/2018
Approval date [1] 299759 0
21/05/2018
Ethics approval number [1] 299759 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81482 0
Dr David Briskey
Address 81482 0
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81482 0
Australia
Phone 81482 0
+61 421 784 077
Fax 81482 0
Email 81482 0
d.briskey@uq.edu.au
Contact person for public queries
Name 81483 0
Amanda Rao
Address 81483 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD 4006
Country 81483 0
Australia
Phone 81483 0
+61 414 488 559
Fax 81483 0
Email 81483 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 81484 0
Amanda Rao
Address 81484 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD 4006
Country 81484 0
Australia
Phone 81484 0
+61 414 488 559
Fax 81484 0
Email 81484 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
123Ethical approval    374606-(Uploaded-06-11-2018-11-46-44)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.