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Trial registered on ANZCTR


Registration number
ACTRN12619001722189
Ethics application status
Approved
Date submitted
27/11/2019
Date registered
6/12/2019
Date last updated
6/12/2019
Date data sharing statement initially provided
6/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an Olive Leaf Extract compared to a placebo on Cold and Flu Symptoms in an Adult
Population – A double blind, randomised controlled trial
Scientific title
Effect of an Olive Leaf Extract compared to a placebo on Cold and Flu Symptoms in an Adult
Population – A double blind, randomised controlled trial
Secondary ID [1] 299933 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ISO-FLU19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Cold 315368 0
Influenza virus infection 315369 0
Condition category
Condition code
Alternative and Complementary Medicine 313670 313670 0 0
Herbal remedies
Infection 313671 313671 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double blind, randomised, clinical study with a maximum 4-month participant duration with 2 groups (1 active ingredient group and 1 inactive placebo group).

Isenolic® is a commercial product standardised for Elenolic acid (ELA). ELA is derived from oleuropein extracted from olive oil and olive leaves.
Each product will be consumed as per the following: One capsule containing 150 mg of olive leaf extract taken twice daily: one capsule in the morning and one capsule in the evening. Capsules are to be taken just prior to or with food.

Once enrolled in the study, participants will be randomly allocated to either a placebo group or an active intervention group. Participants will receive a 2-week supply (28 capsules) of the study product per event. Participants will be asked to start consuming the allocated study product according to the dose prescribed (2 x 150 mg/day) immediately upon the onset of symptoms starting.
During the study period, participants will be asked to only start the trial product once cold or flu symptoms start. Following the onset of symptoms, participants will then be required to record their daily symptoms (including the severity) using the WURSS-21 questionnaire. For participants presenting with flu-like symptoms, they will be asked to take a nasal swab on day 3. If nasal swab is positive for flu virus or if symptoms do not improve after 1 week, participants will be required to seek medical advice (consult a GP). Nasal swabs will be
conducted by a certified commercial pathology laboratory. This will be tested for disease aetiology. Once symptoms have subsided, participants will stop taking the trial product.
A participant may record more than 1 cold or flu episode. However, there must be a minimum 2-week symptom free period between events. Maximum treatment duration is up to 8 weeks with a two week symptom free period in between episodes.
Intervention code [1] 316200 0
Treatment: Other
Comparator / control treatment
Maltodextrin encapsulated in an opaque capsule - identical to active product
Control group
Placebo

Outcomes
Primary outcome [1] 322094 0
Change in cold or flu duration as assessed by WURSS-21 scores
Timepoint [1] 322094 0
Submitted daily during cold or flu symptom episode.
Secondary outcome [1] 377318 0
Change in cold or flu severity
Timepoint [1] 377318 0
Assessed by WURSS-21 scores daily during cold or flu symptoms
Secondary outcome [2] 377319 0
Tolerance of product as assessed by Gastrointestinal Tolerance questionnaire
Timepoint [2] 377319 0
At the end of 2 week supplementation period
Secondary outcome [3] 377320 0
Any missed days from work as self reported
Timepoint [3] 377320 0
Reported at end of 2 week supplementation period

Eligibility
Key inclusion criteria
Male and females 18-65 years old
Generally healthy - Absence of chronic sickness (EPOC, metabolic stress related diseases)
Able to provide informed consent
Minimum age
18 Years
Maximum age
65 Years
Gender
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, lung conditions or chronic asthma)*
Acute sickness experienced in the past 2 months
Serious mood disorders or neurological disorders such as MS
Active smokers and/or nicotine or drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
Pregnant or lactating woman
People medically prescribed to take drugs that would affect the immune and/or the inflammatory
response.
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other related clinical study during the past 1 month
People with cognitive damage
People who have had treatment for cancer, HIV or chronic use of steroids
BMI >40

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

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)
Methods used to generate the sequence in which subjects will be randomised (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
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

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 in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304393 0
Commercial sector/Industry
Name [1] 304393 0
Pharmactive
Address [1] 304393 0
Avenida del Doctor Severo Ochoa, 37.
Local 4J, 28108 Alcobendas, Madrid.
Country [1] 304393 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Pharmactive
Address
Avenida del Doctor Severo Ochoa, 37.
Local 4J, 28108 Alcobendas, Madrid.
Country
Spain
Secondary sponsor category [1] 304652 0
Commercial sector/Industry
Name [1] 304652 0
Amanda Rao - RDC Global Pty Ltd
Address [1] 304652 0
3B/76 Doggett St
Newstead QLD 4006
Country [1] 304652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304831 0
Bellberry Limited
Ethics committee address [1] 304831 0
123 Glen Osmond Road,
Eastwood, South Australia 5063.
Ethics committee country [1] 304831 0
Australia
Date submitted for ethics approval [1] 304831 0
17/07/2019
Approval date [1] 304831 0
22/11/2019
Ethics approval number [1] 304831 0

Summary
Brief summary
This is a double blind, randomised, clinical study with a maximum 4-month participant duration with 2 groups (1 active ingredient group and 1 inactive placebo group). Isenolic® is a commercial product standardised for Elenolic acid (ELA). ELA is derived from oleuropein extracted from olive oil and olive leaves. The aim of this study is to assess the effectiveness of an olive leaf extract (standardised for elenolic acid) on reducing cold and flu duration and severity in otherwise healthy adults aged over 18 years, compared to a placebo.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98350 0
Dr David Briskey
Address 98350 0
RDC Global Pty Ltd
3B/76 Doggett St
Newstead QLD 4006
Country 98350 0
Australia
Phone 98350 0
+61421 784 077
Fax 98350 0
Email 98350 0
d.briskey@uq.edu.au
Contact person for public queries
Name 98351 0
Ms Amanda Rao
Address 98351 0
RDC Global Pty Ltd
3B/76 Doggett St
Newstead QLD 4006
Country 98351 0
Australia
Phone 98351 0
+61414 488 559
Fax 98351 0
Email 98351 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 98352 0
Ms Amanda Rao
Address 98352 0
RDC Global Pty Ltd
3B/76 Doggett St
Newstead QLD 4006
Country 98352 0
Australia
Phone 98352 0
+61414 488 559
Fax 98352 0
Email 98352 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 data will be shared
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5910 0
Ethical approval
Citation [1] 5910 0
Link [1] 5910 0
Email [1] 5910 0
Other [1] 5910 0
Summary results
No Results