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Trial registered on ANZCTR


Registration number
ACTRN12618000285257
Ethics application status
Approved
Date submitted
13/02/2018
Date registered
23/02/2018
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled study to evaluate the effect of orally-dosed LipiSperse curcumin and/or palmitoylethanolamide (PEA) on exercise recovery in healthy males.
Scientific title
A double-blind, randomised, placebo-controlled study to evaluate the effect of orally-dosed LipiSperse curcumin and/or palmitoylethanolamide (PEA) on exercise recovery in healthy males.
Secondary ID [1] 294039 0
CUR-REC18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise recovery 306578 0
Condition category
Condition code
Alternative and Complementary Medicine 305673 305673 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Product 1, LipiSperse Curcumin: Each dose will contain 500 mg of curcumin consumed as a drink
Product 2, PEA: Each dose will contain 150 mg of PEA consumed as a drink

This is a double-blind, randomised, clinical trial with a 72-hour treatment duration with 3 arms (2 active
ingredient arms and 1 placebo arm).
Participants will be recruited from databases and public media outlets. Following preliminary screening
via telephone, potential participants will attend the clinic for an information session and will be required
to provide their consent for inclusion in the trial. Consenting participants will undergo a health
assessment including lifestyle, current medications and medical history; this data will be used for the
comprehensive screening and to provide contextual data for the study.
Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group
or one of two active intervention groups. Prior to treatment, participant’s blood will be collected (20 mL)
for analysis. Specifically, myoglobin, creatine kinase, lactate dehydrogenase, lactate, CRP, IL-6, IL-10,
TFN-a, P38, antioxidant potential including glutathione, curcumin and/or PEA concentration, ELF/T and
FBC.
Participants will be asked to consume the allocated product according to the dose prescribed. An
opaque packet will be provided to the study coordinator with group allocation and the contained powder
will be mixed with 250 ml of water. Each packet will contain ~1 g of study product (500 mg Lipisperse
curcumin and 500 mg of maltodextrin, 150 mg of PEA and 850 mg of maltodextrin, or 1 g of maltodextrin)
which is colour and flavour matched (orange). Following this (30-60 minutes), participants will
undergo a bout of exercise to induce local muscle fatigue. To reduce the risk of injury, participants
will complete an adequate warm-up consisting of stretching of major muscle groups and 5-10 minutes
of easy cycling (60 rpm, 5 RPE) on a cycling ergometer before attempting any exercise.
Muscle fatigue will be induced using leg press and completion of 4 sets for as many reps as possible
with a 2-minute rest in between sets. First, a participant’s maximum leg press strength will be measured
before they complete 4 sets of as many reps as possible at 80% of maximal leg press. Once a participant
has completed the 4 sets, the participant will consume the supplement (placebo or active) and rest.
Movement within this period will be limited to walking limited distance and sitting.

Following a 90-120-minute rest period, the participant will again complete leg press reps at 70% of
maximal until exhaustion. The number of reps completed will be converted to a percentage out of 50
reps to calculate performance. A power meter will also be used to measure maximum leg press
repetition velocity and power, average velocity and power, and total work performed and
each
participant completes for a repetition of leg press by the time it takes them to perform it. Although
absolute weight moved is valuable data, power, rate of force production, acceleration, velocity, and
deceleration are useful in determination of movement and muscular kinetics.
Leg press strength will be measured by Alistair Mallard, or a qualified professional hired by RDC Global.
The gold standard, and common practice, 1 RM testing protocol will be used. After warming up, the load
will be set at 90% of the predicted 1 RM, and increased after each successful lift until failure. Periods of
rest (approximately 3–5 min) will be allotted between each attempt to ensure recovery. A test will be
considered valid if the subject uses proper form and completes the entire lift in a controlled manner
without assistance. A warm-down will occur after exercise sessions by repeating the same protocol as
the warm-up.
During each exercise component of the trial, correct form will be taught and constantly assessed by the
administrator to help reduce the risk of injury. In the event that an injury is experienced, participants are
to consult with the trial coordinator as soon as possible. For every visit to RDC Global, water will be
available as desired (this includes the period prior to arriving). Water intake is expected to have no
influence on the results of this trial.
Further blood will be taken from participants immediately after the muscle fatigue sets, during the rest
period, immediately before and after the performance trial and 60 minutes after the performance trial.
Blood will also be taken at 24, 48 and 72 hours post exercise.
Participants are asked to refrain from any strenuous activity for the 96 hours of the study protocol.
Muscle soreness will be assessed at baseline and 24, 48 and 72 hours post exercise by a VAS and
questionnaire. Thigh circumference will be measured using a tape measure at the mid-point between
the top of the knee (patella) and the crease at the top of the thigh.
Intervention code [1] 300309 0
Treatment: Other
Comparator / control treatment
Product 3, placebo is made up of water and orange flavour only.

Treatment 1 is curcumin and Treatment 2 is PEA.
Control group
Placebo

Outcomes
Primary outcome [1] 304771 0
Change in creatine kinase via serum assau
Timepoint [1] 304771 0
Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise (primary endpoint)
Secondary outcome [1] 343099 0
Change in myoglobin via serum assay
Timepoint [1] 343099 0
Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [2] 343100 0
change in lactate dehydrogenase via serum assay
Timepoint [2] 343100 0
Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [3] 343101 0
Muscle pain (Delayed on-set muscle soreness) measured by VAS pan score
Timepoint [3] 343101 0
Baseline, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [4] 343102 0
serum lactate as a measure of inflammation and antioxidant capacity
Timepoint [4] 343102 0
Baseline, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [5] 343103 0
C-reactive protein as a measure of inflammation and antioxidant capacity via serum assay
Timepoint [5] 343103 0
Baseline, 24, 48 and 72 hours post exercise
Secondary outcome [6] 343104 0
IL-6 as a measure of inflammation and antioxidant capacity via serum assay
Timepoint [6] 343104 0
Baseline, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [7] 343105 0
TNF-a as a measure of inflammation and antioxidant capacity via serum assay
Timepoint [7] 343105 0
Baseline, 24, 48 and 72 hours post exercise
Secondary outcome [8] 343106 0
IL-10 as a measure of inflammation and antioxidant capacity via serum assay
Timepoint [8] 343106 0
Baseline, 24, 48 and 72 hours post exercise
Secondary outcome [9] 343107 0
P38 as a measure of inflammation and antioxidant capacity via serum assay
Timepoint [9] 343107 0
Baseline, 24 hours, 48 hours and 72 hours post exercise
Secondary outcome [10] 343108 0
Gastrointestinal Tolerance scale - a questionnaire used in other studies to assess the tolerance of supplements
Timepoint [10] 343108 0
Baseline and 72 hours
Secondary outcome [11] 343109 0
Serum curcumin via serum assay
Timepoint [11] 343109 0
Baseline and 72 hours post exercise
Secondary outcome [12] 343110 0
Fatigue as measured by Multidimensional symptoms fatigue inventory
Timepoint [12] 343110 0
Baseline and 72 hours post exercise
Secondary outcome [13] 343111 0
Pain as measured by KOOS/McGill pain
Timepoint [13] 343111 0
Baseline and 72 hours post exercise
Secondary outcome [14] 343112 0
Muscle swelling as measured by participant thigh circumference
Timepoint [14] 343112 0
Baseline and 72 hours post exercise
Secondary outcome [15] 343606 0
serum PEA concentrations via serum assay
Timepoint [15] 343606 0
Baseline and 72 hours post exercise

Eligibility
Key inclusion criteria
Recreationally trained males (150 minutes of exercise per week and 6 months of resistance training experience in the last year) between 18 and 35 years old
Normal dietary habits (no medically prescribed diet, no slimming diet, no vegan or macrobiotic diet)
Otherwise healthy, BMI 18.5-35
Able to provide informed consent
Minimum age
18 Years
Maximum age
35 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes)
Use of long-term medication
Malignancy or treatment for malignancy within the previous 2 years
Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin
or other anticoagulation therapy
Active smokers
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
People with serious mood disorders (such as depression and bipolar disorder)
will be excluded. The Hamilton Rating Scale for Depression could be used as a screening form to ensure that those with undiagnosed depression are not enrolled into the study.
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. This include existing and recent musculoskeletal
injuries.
Participants who have participated in any other clinical trial during the past 3
months.

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

Recruitment
Recruitment status
Completed
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] 298664 0
Commercial sector/Industry
Name [1] 298664 0
Gencor Pacific
Address [1] 298664 0
21-E, Elegance Court
Hillgrove Village
Discovery Bay, 29876802
Hong Kong
Country [1] 298664 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] 297832 0
Commercial sector/Industry
Name [1] 297832 0
Pharmako Biotechnologies Pty Ltd
Address [1] 297832 0
Campbell Ave Cromer, NSW 2099
Country [1] 297832 0
Australia
Secondary sponsor category [2] 297922 0
Commercial sector/Industry
Name [2] 297922 0
Gencor Pacific
Address [2] 297922 0
21-E, Elegance Court
Hillgrove Village
Discovery Bay, 29876802
Hong Kong
Country [2] 297922 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299618 0
BellBerry Ltd
Ethics committee address [1] 299618 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 299618 0
Australia
Date submitted for ethics approval [1] 299618 0
09/11/2017
Approval date [1] 299618 0
03/03/2018
Ethics approval number [1] 299618 0

Summary
Brief summary
A double-blind, randomised, placebo-controlled study to evaluate the effect of orally-dosed LipiSperse curcumin and/or palmitoylethanolamide (PEA) on exercise recovery in healthy males.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81050 0
Dr David Briskey
Address 81050 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81050 0
Australia
Phone 81050 0
+61 421 784 077
Fax 81050 0
Email 81050 0
d.briskey@uq.edu.au
Contact person for public queries
Name 81051 0
Ms Amanda Rao
Address 81051 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81051 0
Australia
Phone 81051 0
+ 61 414 488 559
Fax 81051 0
Email 81051 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 81052 0
Ms Amanda Rao
Address 81052 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81052 0
Australia
Phone 81052 0
+61 414 488 559
Fax 81052 0
Email 81052 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?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 127 0
Ethical approval
Citation [1] 127 0
Link [1] 127 0
Email [1] 127 0
Other [1] 127 0
Type [2] 139 0
Ethical approval
Citation [2] 139 0
Link [2] 139 0
Email [2] 139 0
Other [2] 139 0
Type [3] 140 0
Ethical approval
Citation [3] 140 0
Link [3] 140 0
Email [3] 140 0
Other [3] 140 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary