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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.

Phase 3
Completed
Conditions
Exercise recovery
Alternative and Complementary Medicine - Herbal remedies
Registration Number
ACTRN12618000285257
Lead Sponsor
RDC Global Pty Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Male
Target Recruitment
42
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

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in creatine kinase via serum assau[Baseline, 120min, 180min, 24 hours, 48 hours and 72 hours post exercise (primary endpoint)]
Secondary Outcome Measures
NameTimeMethod
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