None listed
Conditions
Brief summary
Curcumin is a well-evidenced and widely administered supplemental compound. Previous studies have demonstrated its capacity to reduce inflammation and associated physical manifestations. A large body of evidence has also confirmed that ingestion can attenuate oxidative damage. However, the bioavailability of naturally occurring curcumin is poor. Fortunately a novel curcumin formulation, using LipiSperse® technology, has been developed which increases plasma curcuminoids concentration three times compared to raw curcumin. While the safety of this novel formulation has been demonstrated (TGA listed) its effectiveness to reduce markers of inflammation and oxidative damage is not yet known. Therefore the objective of this double blind, placebo controlled trial is to investigate, in healthy humans, the efficacy of the novel curcumin formulation (with LipiSperse® technology) to reduce markers of inflammation and oxidative stress compared to both natural curcumin (without LipiSperse® technology) and a placebo control.
Interventions
Participants will be randomised to one of 3 study arms.
Group 1 Placebo (Silicon dioxide, red & yellow food colouring), n=15
Group 2 Novel curcumin formulation using LipiSperse® technology (listed in Therapeutic Goods Administration (TGA) as Hydrocurc; ARTG ID 295857) - 752 mg of curcuminoids equivalent; 376 mg curcuminoids twice daily, before meals, n=15
Group 3 Curcumin without LipiSperse® technology - 752 mg curcumin equivalent; 376 mg curcuminoids twice daily, before meals, n=15
Mode of adm
Participants will be randomised to one of 3 study arms. Group 1 Placebo (Silicon dioxide, red & yellow food colouring), n=15 Group 2 Novel curcumin formulation using LipiSperse® technology (listed in Therapeutic Goods Administration (TGA) as Hydrocurc; ARTG ID 295857) - 752 mg of curcuminoids equivalent; 376 mg curcuminoids twice daily, before meals, n=15 Group 3 Curcumin without LipiSperse® technology - 752 mg curcumin equivalent; 376 mg curcuminoids twice daily, before meals, n=15 Mode of administration- oral capsule Duration of study - 8 weeks Blood samples will be collected for testing at baseline 2, 4, 6 and 8 weeks
Sponsors
Australasian Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Participants recruited into this study will be males and/or females aged between 40 and 60 years who: • are not currently taking any pharmacotherapies for inflammatory disorders including, rheumatoid arthritis and other autoimmune conditions including, Lupus, MS, Guillian-Barre syndrome, psoriasis etc. • do not have impaired renal function, • do not regularly take aspirin, ibuprofen or other anti-inflammatory medications, • are willing to cease supplementation(e.g. antioxidants, flavonoids, minerals, omega-3 etc) for at least 7 days before the start of this study, and are willing to refrain from taking additional supplements for the duration of the trial, • have no known sensitivity to turmeric, curcumin or its metabolites, or red/yellow food colouring, • have an hsCRP between 2.5 – 10.00 µg/mL, • are not pregnant
Exclusion criteria
- Are currently taking anti-inflammatory medication - Are cognitively impaired and/or are unable to give informed consent for any reason
Outcome results
None listed