None listed
Conditions
Brief summary
This randomised, double-blind, placebo-controlled trial aims to investigate the effects of 12 weeks of supplementation with a bioavailability enhanced curcumin supplement, Longvida (registered trademark) Optimized Curcumin, on cognition and mood and wellbeing, in healthy individuals aged 50 to 85 years. To better understand how cognitive and mood benefits might be achieved the study will also investigate the effects of curcumin on cardiovascular function and a range of blood markers of health. In a subset of participants an MRI component of the study will explore the effects of curcumin on brain function. Finally the study will investigate whether difference in genetic make-up influence the effects of curcumin. Participants will attend 4 study visits; a practice and screening visit at which consent will be taken, eligibility will be ensured and participants will be familiarised with study measures and procedures, and assessment visits as baseline, 4 weeks and 12 weeks. Participants taking part in the fMRI part of the trial will complete 2 additional assessment which, where possible, will be performed on the same day as their baseline and 12 week study visits.
Interventions
Twelve weeks supplementation with curcumin formulation (Longvida (Registered Trademark) Optimized Curcumin 400mg, containing about 80- 90mg curcumin), taken as a single daily capsule..
Treatment compliance will be monitored by a count of unused capsules at returned visits (primary compliance measure), the use of a daily treatment log completed by participants throughout the study (secondary compliance measure).
Sponsors
Swinburne University of Technology, Centre for Human Psychopharmacology
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
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 50-85 years. 2. Willing and able to provide written informed consent. 3. Understand and willing and able to comply with all study procedures. 4. No history of stroke, neurological conditions (e.g. Parkinson’s, epilepsy), depression, psychiatric disorders, low base line intellect, alcohol abuse past / present. 5. Free from dementia. 6. Fluent in written and spoken English. 7. Must have normal or corrected vision and not colour blind. 8. Free from medical conditions which may affect ability to participate in the study 9. Participants taking part in the MRI sub-study must be right handed
Exclusion criteria
1. Any significant concurrent illness including any auto-immune disorder, bleeding disorders, currently impaired cardiovascular function, Type I diabetes, glaucoma, uncontrolled high blood pressure or gallstones. 2. Any known or suspected food allergies 3. Smokers and users of recreational drugs (except alcohol and other food grade actives). 4. Have participated in any other study involving an investigational product in the last 4 weeks. 5. Taking anti-coagulant drugs or anti-cholinergics or acetylcholinesterase inhibitors. 6. Taking steroid medications. 7. Taking vitamins or herbal supplements that are reasonably expected to influence study measures. 8. Left-handed participants will be ineligible to take part in the MRI sub-study.
Outcome results
None listed