ANZCTR - Registration

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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]

CUR-REC18

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Exercise recovery

Condition category

Condition code

Alternative and Complementary Medicine

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]

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]

Change in creatine kinase via serum assau

Timepoint [1]

Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise (primary endpoint)

Secondary outcome [1]

Change in myoglobin via serum assay

Timepoint [1]

Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [2]

change in lactate dehydrogenase via serum assay

Timepoint [2]

Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [3]

Muscle pain (Delayed on-set muscle soreness) measured by VAS pan score

Timepoint [3]

Baseline, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [4]

serum lactate as a measure of inflammation and antioxidant capacity

Timepoint [4]

Baseline, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [5]

C-reactive protein as a measure of inflammation and antioxidant capacity via serum assay

Timepoint [5]

Baseline, 24, 48 and 72 hours post exercise

Secondary outcome [6]

IL-6 as a measure of inflammation and antioxidant capacity via serum assay

Timepoint [6]

Baseline, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [7]

TNF-a as a measure of inflammation and antioxidant capacity via serum assay

Timepoint [7]

Baseline, 24, 48 and 72 hours post exercise

Secondary outcome [8]

IL-10 as a measure of inflammation and antioxidant capacity via serum assay

Timepoint [8]

Baseline, 24, 48 and 72 hours post exercise

Secondary outcome [9]

P38 as a measure of inflammation and antioxidant capacity via serum assay

Timepoint [9]

Baseline, 24 hours, 48 hours and 72 hours post exercise

Secondary outcome [10]

Gastrointestinal Tolerance scale - a questionnaire used in other studies to assess the tolerance of supplements

Timepoint [10]

Baseline and 72 hours

Secondary outcome [11]

Serum curcumin via serum assay

Timepoint [11]