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Trial registered on ANZCTR


Registration number
ACTRN12619001467123
Ethics application status
Approved
Date submitted
3/10/2019
Date registered
23/10/2019
Date last updated
23/10/2019
Date data sharing statement initially provided
23/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Palmitoylethanolamide (PEA) or Curcumin on Joint Health in an adult population when compared to a placebo - a randomised, double blind interventional study.
Scientific title
Joint Health in an Adult Population - PEA or Curcumin Compared to a Placebo in A
randomised, double-blinded study
Secondary ID [1] 299468 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint Pain 314686 0
Condition category
Condition code
Musculoskeletal 313034 313034 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Palmitoylethanolamide (PEA) or Curcumin (2 arm study).

Participants will take 1 capsule containing 175 mg of PEA twice daily for 2 weeks (1 capsule in the morning and 1 capsule in the evening).

OR

One capsule containing a total 500 mg of HydroCurc taken daily in the evening before bed for 2 weeks.

Compliance will be monitored via capsule return at the end of the study.
Intervention code [1] 315721 0
Treatment: Drugs
Comparator / control treatment
In this study there are two placebo comparator groups:
Placebo - PEA: The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. It will be administered as two capsules using the same procedure detailed above for PEA.

OR

Placebo - Curcumin: The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. It will be administered as a single capsule using the same procedure detailed above for curcumin.

Compliance will be monitored via capsule return at the end of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 321586 0
Change in joint pain as measured by Visual Analog Scale (VAS).
Timepoint [1] 321586 0
Baseline, Daily for 2 weeks
Secondary outcome [1] 375482 0
Change in weight as measured by digital scales
Timepoint [1] 375482 0
Baseline, Day 14
Secondary outcome [2] 375483 0
Change in quality of life as measured by SF-36, POMS and GI tolerance questionnaires.
Timepoint [2] 375483 0
Baseline, Day 14
Secondary outcome [3] 375484 0
Composite outcome: Change in systemic inflammation as measured by TNF-a, TGF-b, IL-1B, IL-6, IL-8, IL-10, hs-CRP with analysis by serum assay.
Timepoint [3] 375484 0
Baseline, Day 14
Secondary outcome [4] 375486 0
Composite outcome: General safety markers using E/LFT panel: Albumin, alkaline phosphatase, ALT, AST, GGT, cholesterol, HLD, LDL, triglycerides, urea, creatinine, glucose and total protein. Analysis via serum assay.
Timepoint [4] 375486 0
Baseline, Day 14

Eligibility
Key inclusion criteria
Male and females 25-70 years old
Reporting joint pain (not associated with acute injury or long-standing disease)
Generally healthy
Able to provide informed consent
If female, must use either a prescribed form of birth control, are abstinent or post-menopausal
Agree not to change current diet or exercise during the study
Agree not to take any pain medication during the study
Minimum age
25 Years
Maximum age
70 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)*
Malignancy or treatment for malignancy within the previous 2 years
Diagnosed rheumatoid arthritis, bursitis and/or gout
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
anticoagulation therapy
Serious mood disorders or neurological disorders such as MS
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (more than 14 standard alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
Known pregnant or lactating woman
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
History of infection in the month prior to the study

*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 3 / Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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] 303968 0
Commercial sector/Industry
Name [1] 303968 0
Gencor Pacific
Address [1] 303968 0
Unit 3, 1/F, Office Building Block 2,
96 Siena Avenue, Discovery Bay North,
Lantau Island, N.T., Hong Kong
Country [1] 303968 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] 304138 0
Commercial sector/Industry
Name [1] 304138 0
Pharmako Biotechnologies Pty Ltd
Address [1] 304138 0
36 Campbell Ave, Cromer NSW 2099
Country [1] 304138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304468 0
Bellberry Human Research Ethics Committee Fullboard
Ethics committee address [1] 304468 0
123 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 304468 0
Australia
Date submitted for ethics approval [1] 304468 0
Approval date [1] 304468 0
11/09/2019
Ethics approval number [1] 304468 0

Summary
Brief summary
This is a double-blind, randomised, clinical study with a 14-day treatment duration with 2 arms (with 2 active ingredient groups and 2 placebo groups). The aim of this study is to assess the effectiveness of PEA and curcumin on reducing joint pain in otherwise healthy adults aged 25-70 years, compared to a placebo. A placebo is a substance with no therapeutic effect, in this case maltodextrin.

Participants will be asked to attend our clinic to complete their enrolment with a Trial Coordinator. During this visit, they will also complete an initial assessment including, letting the trial coordinator know about their joint pain and general health by completing questionnaires; height and weight measurements; and a blood test.
At the conclusion of the visit, participants will be randomly allocated to either the PEA, curcumin or placebo treatment group.

Once enrolled in the study, participants will be asked to complete 3 days of pain recording (once morning and once at night) online.
Following the completion of the 3 days of pain recording, trial coordinators will confirm supplementation commencement. Capsules should be consumed as described on the label.
Once supplementation has started, participants will be required to record their pain level every morning upon waking, and every night prior to going to bed for 2 weeks.
At the completion of the 2 weeks, participants will be required to attend the clinic for a final appointment where they will complete identical assessments to the initial visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97050 0
Dr David Briskey
Address 97050 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 97050 0
Australia
Phone 97050 0
+61 421 784 077
Fax 97050 0
Email 97050 0
d.briskey@uq.edu.au
Contact person for public queries
Name 97051 0
Ms Amanda Rao
Address 97051 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 97051 0
Australia
Phone 97051 0
+61 414 488 559
Fax 97051 0
Email 97051 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 97052 0
Ms Amanda Rao
Address 97052 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 97052 0
Australia
Phone 97052 0
+61 414 488 559
Fax 97052 0
Email 97052 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
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5202 0
Ethical approval
Citation [1] 5202 0
Link [1] 5202 0
Email [1] 5202 0
Other [1] 5202 0
Summary results
No Results