None listed
Conditions
Brief summary
This study aims to investigate the efficacy of palmitoylethanolamide (PEA) and probiotics for wellbeing and osteoarthritic pain. The primary hypothesis is that oral administration of PEA and probiotics will be associated with a decrease in pain, as measured by a numerical rating scale, in comparison with a placebo. The active interventions include a probiotic (including three different strains) and a form of micronized PEA. Participants will be asked to take one capsule of each intervention in the morning after meals and another capsule of each intervention in the evening after meals.
Interventions
The trial will be an 11 week multiple baseline design with two pathways. Both pathways commence with a baseline (placebo) phase followed by the treatment pathway. As a result there is no washout period between the placebo phase and the treatment phase. Each participant will be assigned to one of two pathways.
Pathway 1:
Active 1 (Metagenics Ultra Flora Intensive Care) will be taken as one capsule twice daily for 7 weeks AND Active 2 (Bioabsorb PEA) will be taken as one capsule twice daily fo
The trial will be an 11 week multiple baseline design with two pathways. Both pathways commence with a baseline (placebo) phase followed by the treatment pathway. As a result there is no washout period between the placebo phase and the treatment phase. Each participant will be assigned to one of two pathways. Pathway 1: Active 1 (Metagenics Ultra Flora Intensive Care) will be taken as one capsule twice daily for 7 weeks AND Active 2 (Bioabsorb PEA) will be taken as one capsule twice daily for 7 weeks. Pathway 2: Active 1 (Metagenics Ultra Flora Intensive Care) will be taken as one capsule twice daily for 9 weeks AND Active 2 (Bioabsorb PEA) will be taken as one capsule twice daily for 9 weeks. Please note that participants will be taking BOTH Active 1 and Active 2 at the same time during the active phases of their respective pathways. Adherence to the intervention ill be through supplement capsule return, verbal questioning at scheduled consultations. During the active phases, participants will take the following: Active 1: Metagenics Ultra Flora Intensive Care (ARTG Entry: 286746) at a dose of one capsule twice daily. Each capsule is 600mg in a clear (00 size Vcap with cream coloured powder) capsule containing Lactobacillus rhamnosus (LGG®) (10 x 109CFU), Saccharomyces cerevisiae (boulardii) (7.5 x 109 CFU) and Bifidobacterium animalis ssp lactis (BB-12®) (5 x 109 CFU). Active 2: Metagenics Bio Absorb PEA (ARTG Entry: 330607) at a dose of one capsule twice daily. Each capsule is 300mg with a dark green capsule (Vcap with cream coloured powder) containing palmidrol 299.99mg per capsule. Participants will be asked to take this dose (a total of 600mg daily for 6 – 8 weeks) as it represents the minimum ‘loading dose’ as well as the maximum ‘maintenance dose’ to ensure continuity.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
• Individuals aged between 18 and 85 years • Medical diagnosis or clinical evidence of osteoarthritis in any site • Individuals who describe chronic/symptomatic osteoarthritic pain in the affected joint • In good general health • Female participants of childbearing age who agree to continue using birth control measures for the duration of the study
Exclusion criteria
• A history of trauma associated with the affected joint • Rheumatoid arthritis or other inflammatory joint conditions • Recent history gout • Individuals with diabetes • Individuals with a compromised immune system • Individuals taking antidepressant medications for less than 6 months or who have experienced psychological side effects as a result of antidepressant medication in the last 6 months. • Individuals taking Warfarin or other anti-coagulant medication • Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study • Female participants who are lactating, pregnant or planning to become pregnant • Participants who have participated in another clinical trial in the last 30 days • Participants unwilling to comply with the study protocol • Any other condition, which in the opinion of the investigators could compromise the study
Outcome results
None listed