Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001050943p
Ethics application status
Not yet submitted
Date submitted
18/08/2020
Date registered
15/10/2020
Date last updated
15/10/2020
Date data sharing statement initially provided
15/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of BerriQi® Boysenberry and apple beverage on lung health of individuals with sarcoidosis.
Scientific title
Impact of BerriQi® Boysenberry and apple beverage on lung health and of individuals with sarcoidosis.
Secondary ID [1] 302059 0
None
Universal Trial Number (UTN)
U1111-1257-1153
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary sarcoidosis 318659 0
Condition category
Condition code
Inflammatory and Immune System 316677 316677 0 0
Other inflammatory or immune system disorders
Respiratory 316678 316678 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study duration is 12 weeks; 2-week lead-in period for screening, recruitment, and baseline measurements, followed by a 4-week intervention period, a 2-week washout period, followed by another 4-week intervention period.

Participants will be recruited from sarcoidosis support e-groups. The aims of the study and investigational product will be described, along with descriptions of the questionnaires and the medical data sought, and information for their healthcare providers. It is expected that motivated support e-group members will volunteer to participate. Following emailed confirmation of participation, receipt of written informed consent and appropriateness of volunteered data, participants will be courier-posted to consume daily, for 4 weeks, either a 30 mL berry fruit beverage (BerriQi®) or a heat-inactivated version (placebo) and asked to continue to volunteer appropriate medical data from their usual medical monitoring regime. Participants will continue with their usual ongoing medical treatment. After 4 weeks, participants will have a 2 week washout period, followed by another 4-week intervention period where they will be sent to consume daily , either a 30 mL berry fruit beverage (BerriQi®) or a heat-inactivated version (placebo) and continue to volunteer medical data.

At baseline (Day 0), midpoint (Day 14) and endpoint (Day 28) of each intervention, participants will complete questionnaires to assess their dietary habits as a means of ensuring compliance and to remind them to avoid berry-based foods, and at the beginning (Day 0) and end (Day 28) of each intervention to assess their lung health.

Participants will provide lung function and liver function tests, obtained from their healthcare provider at the beginning (Day 0) and end (Day 28) of each intervention as a part of the routine monitoring of their condition. These results will be sent by email.

This study will be conducted entirely online with investigational product and placebo sent by mail. Used and unused bottles will be returned by mail to check compliance.
Intervention code [1] 318361 0
Treatment: Other
Comparator / control treatment
This is a randomised placebo controlled crossover study. Participants will be randomised to recieve and drink either 30 mL BerriQi fruit drink or 30 mL heat-inactivated BerriQi (experimentally determined in preclinical studies to not provide benefits observed with active BerriQi) daily for 28 days for the first intervention period, and after a 2 week washout period, the opposite (heat-inactivated placebo or active BerriQi) treatment in the second intervention period.

Participants will continue to recieve their normal medical treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 324803 0
Any change in lung health as assessed by St George's Respiratory Questionnaire
Timepoint [1] 324803 0
Assessed at beginning (Day 0) and end (day 28) of first intervention period, and beginning (Day 42) and end (Day 70) of second intervention period.
Secondary outcome [1] 385786 0
Any change in lung inflammation and systemic inflammation (composite secondary outcome) as assessed by the sarcoidosis biomarker serum angiotensin-converting enzyme (ACE) activity
Timepoint [1] 385786 0
Assessed at beginning (Day 0) and end (day 28) of first intervention period, and beginning (Day 42) and end (Day 70) of second intervention period.
Secondary outcome [2] 385787 0
Any change in lung function (FEV1/FVC ratio) measured using spirometry.
Timepoint [2] 385787 0
Assessed at beginning (Day 0) and end (day 28) of first intervention period, and beginning (Day 42) and end (Day 70) of second intervention period.
Secondary outcome [3] 385788 0
Any change in composite liver function scores assessed by the following tests:
a. Total Bilirubin
b. Alk Phosphatase
c. GGT
d. ALT
e. AST
f. Total Protein
g. Albumin
h. Globulin
Timepoint [3] 385788 0
Assessed at beginning (Day 0) and end (day 28) of first intervention period, and beginning (Day 42) and end (Day 70) of second intervention period.

Eligibility
Key inclusion criteria
a. They are an adult aged 18-65
b. They have had biopsy-proven pulmonary sarcoidosis for at least one year
c. They are on stable medication (e.g. prednisone, other, or none) dose for at least 4 weeks prior to recruitment, and unlikely to change medication during the course of this study
d. They are not currently participating in another clinical interventional study
e. They will provide written informed consent
f. They agree to avoid eating other berry fruits or foods likely to contain berry fruit for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Current or prior (previous four weeks) respiratory tract infection
b. Current or prior eating disorder (e.g. anorexia nervosa, bulimia) that would interfere with consumption and/or absorption of the investigational product
c. Food allergy or intolerance that would compromise compliance with the study protocol, including berry fruits and apples

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Lung function is the primary end point of this study. We were unable to find qualitative data for sarcoidosis studies using the SGRQ to allow a power analysis based on the so-called clinically significant improvement in 4/100. Instead we have calculated power on the basis of FVC improvements in sarcoidosis patients responding to infliximab (Baughman et al., 2006). This study allowed for treatment sample sizes of n=40 with a statistical power of 80% to detect a 10% improvement in FVC. Erring on the side of caution and allowing for larger drop out (incompletion) rates due to the hands-off online crowdsource nature of this study, we figure 55 participants will provide adequate power to establish differences in all end points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2020
Actual
Date of last participant enrolment
Anticipated
23/11/2020
Actual
Date of last data collection
Anticipated
8/02/2021
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment outside Australia
Country [1] 22860 0
New Zealand
State/province [1] 22860 0
all

Funding & Sponsors
Funding source category [1] 306482 0
Commercial sector/Industry
Name [1] 306482 0
Anagenix Ltd
Country [1] 306482 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Anagenix Ltd
Address
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307004 0
None
Name [1] 307004 0
Address [1] 307004 0
Country [1] 307004 0
Other collaborator category [1] 281429 0
Commercial sector/Industry
Name [1] 281429 0
Zestt Wellness
Address [1] 281429 0
30 Lynn St, Dunedin 9010
New Zealand
Country [1] 281429 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306686 0
New Zealand Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 306686 0
Ethics committee country [1] 306686 0
New Zealand
Date submitted for ethics approval [1] 306686 0
19/10/2020
Approval date [1] 306686 0
Ethics approval number [1] 306686 0

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

Contacts
Principal investigator
Name 104674 0
Dr Doug Rosendale
Address 104674 0
Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country 104674 0
New Zealand
Phone 104674 0
+64 9 520 0831
Fax 104674 0
Email 104674 0
doug.rosendale@anagenix.com
Contact person for public queries
Name 104675 0
Darcy Schack
Address 104675 0
Zestt Wellness
30 Lynn St, Dunedin 9010
New Zealand
Country 104675 0
New Zealand
Phone 104675 0
+64 27 599 2255
Fax 104675 0
Email 104675 0
darcy@zesttwellness.com
Contact person for scientific queries
Name 104676 0
Doug Rosendale
Address 104676 0
Anagenix Ltd
PO Box 33964
Takapuna, North Shore
Auckland 0740
New Zealand
Country 104676 0
New Zealand
Phone 104676 0
+64 9 520 0831
Fax 104676 0
Email 104676 0
doug.rosendale@anagenix.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are not asking for participant consent to share their data in this form. They may request their own IPD. All others may view the published data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8824Study protocol  doug.rosendale@anagenix.com or darcy@zesttwellness.com
8825Informed consent form  doug.rosendale@anagenix.com or darcy@zesttwellness.com



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.