Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000017820
Ethics application status
Approved
Date submitted
30/10/2020
Date registered
13/01/2021
Date last updated
17/09/2021
Date data sharing statement initially provided
13/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial.
Scientific title
Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial.
Secondary ID [1] 302658 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OEA-GUT20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut microbiome 319566 0
Gut barrier function 319898 0
Gut biochemistry 319899 0
Condition category
Condition code
Oral and Gastrointestinal 317512 317512 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 317513 317513 0 0
Other alternative and complementary medicine
Metabolic and Endocrine 317834 317834 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). OEA, a metabolite of oleic acid, is a bioactive endocannabinoid-like lipid signalling molecule belonging to the acylglycerol and N-acylethanolamine (NAE) family of endocannabinoids.

PEA (Levagen+) will be taken at a dose of 600mg daily (1 capsule in the morning and one in the evening) for the duration of the intervention period (12 weeks). OEA will be taken at a dose of 300mg daily (1 capsule in the morning and 1 in the evening) for the duration of the intervention period (12 weeks).

Once enrolled in the study, participants will attend the clinic and be randomly allocated to either a placebo group or one of two active intervention groups (OEA and PEA). Participants will be required to complete a number of baseline tests before starting trial product. Participants will be required to complete 4 questionnaires online, provide a blood sample (approximately 20 mL) and basic anthropometric measures before attending an imaging centre for a liver scan. Participants will also be provided with a faecal sample collection kit (with instructions) to take home and provide a baseline sample for microbiome testing. Once all baseline measures have been completed participants will start consuming the allocated study product according to the dose prescribed.
During the 3-month study period, participants will be asked to undertake identical testing at week 6 (mid-point) and week-12 (end-point) of the study. The exceptions are some blood analysis, microbiome testing and the liver scan which will not be undertaken at week 6.

Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.
Intervention code [1] 318945 0
Treatment: Drugs
Comparator / control treatment
The placebo product will be 2 x 300 mg capsules daily containing microcrystalline cellulose (1 in the morning and 1 in the evening) encapsulated in an opaque capsule. It will appear identical to the test products. The placebo will be administered as a single capsule using the same procedure as PEA and OEA.
Control group
Placebo

Outcomes
Primary outcome [1] 325550 0
Change in week 12 microbiome compared to baseline via faecal analysis
Timepoint [1] 325550 0
Baseline, Week 12
Primary outcome [2] 325551 0
Change in week 12 metagenomic profile compared to baseline via faecal analysis
Timepoint [2] 325551 0
Baseline and week 12
Secondary outcome [1] 388360 0
Changes in Gut function (Permeability) via plasma assay
Timepoint [1] 388360 0
Baseline, Week 6 and Week 12
Secondary outcome [2] 388361 0
Changes in Gut function (SCFAs) via faecal analysis
Timepoint [2] 388361 0
Baseline, Week 12
Secondary outcome [3] 388362 0
Changes in inflammation markers (IFN-g, TFN-a, il-2, MCP-2, IL-1b, TGF-s, CRP) via serum assay as composite outcome
Timepoint [3] 388362 0
Baseline, Week 6 and Week 12
Secondary outcome [4] 388363 0
Changes in biochemistry (GLP-1, GST, glutathione, FABP, Homocysteine) via blood analysis as composite outcome
Timepoint [4] 388363 0
Baseline, Week 6 and Week 12
Secondary outcome [5] 388364 0
Changes in dietary (Kj) intake as assessed by 24-hour dietary recall diary
Timepoint [5] 388364 0
Baseline, Week 6 and Week 12
Secondary outcome [6] 388365 0
Quality of life as assessed by SF-36 Quality of Life questionnaire
Timepoint [6] 388365 0
Baseline, Week 6 and Week 12
Secondary outcome [7] 388366 0
Changes in sleep quality as assessed by Pittsburgh Sleep Quality Index
Timepoint [7] 388366 0
Baseline, week 6 and week 12
Secondary outcome [8] 388367 0
Changes in stress levels as assessed by Perceived Stress Scale (PSS)
Timepoint [8] 388367 0
Baseline, Week 6 and Week 12

Eligibility
Key inclusion criteria
• Male and females aged 18-65 years old
• Able to provide informed consent
• BMI 30-40kg/m2
Minimum age
18 Years
Maximum age
65 Years
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, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)(a).
• Acute sickness experienced within the past 2 months
• Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study.
• Active smokers and/or nicotine or drug abuse
• Chronic alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in active or placebo formula
• Pregnant or lactating woman
• Females of child bearing potential not using a highly effective form of contraception (b,c) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon) (b,c).
• People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics).
• 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 or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year

a 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.

b Examples of acceptable forms of highly effective contraception include:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• True abstinence: When this is in line with your preferred and usual lifestyle

c Examples of non-acceptable methods of contraception include:
• Condoms alone or double barrier
• Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation)
• Withdrawal
• Spermicide (as it is not approved as a method of contraception in Australia)

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 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307097 0
Commercial sector/Industry
Name [1] 307097 0
Gencor Pacific
Country [1] 307097 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 307666 0
Commercial sector/Industry
Name [1] 307666 0
Pharmako Biotechnologies Pty Ltd
Address [1] 307666 0
36 Campbell Ave, Cromer NSW 2099
Country [1] 307666 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307212 0
Bellberry Limited
Ethics committee address [1] 307212 0
Ethics committee country [1] 307212 0
Australia
Date submitted for ethics approval [1] 307212 0
Approval date [1] 307212 0
03/11/2020
Ethics approval number [1] 307212 0

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

Contacts
Principal investigator
Name 106422 0
Dr David Briskey
Address 106422 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 106422 0
Australia
Phone 106422 0
+61 421 784 077
Fax 106422 0
Email 106422 0
[email protected]
Contact person for public queries
Name 106423 0
Amanda Rao
Address 106423 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 106423 0
Australia
Phone 106423 0
+61 414 488 559
Fax 106423 0
Email 106423 0
[email protected]
Contact person for scientific queries
Name 106424 0
Amanda Rao
Address 106424 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 106424 0
Australia
Phone 106424 0
+61 414 488 559
Fax 106424 0
Email 106424 0
[email protected]

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?

No Supporting Document Provided



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.