None listed
Conditions
Brief summary
The aim of this study is to investigate the acute and chronic effects of LONGVIDA® Optimized Curcumin on cognitive function, mood and potential biomarkers of action in older individuals who are either cognitively healthy or show evidence of cognitive decline. Participants will attend Swinburne University Hawthorn for one screening and practice visit, during which informed consent will be obtained, eligibility will be confirmed and participants will be familiarised with study measures. In Stage One of the study participants will attend two testing sessions at baseline and four-weeks. During these sessions a fasting blood sample will be collected and participants will complete cognitive and mood assessments prior to treatment administration, one hour post administration and three hours post administration. Between testing sessions participants will be required to take one capsule (curcumin or placebo) every day between breakfast and lunch. At the conclusion of Stage One a subset of participants will be invited to complete Stage Two of the study. In stage Two participants will complete two testing sessions at baseline and eight weeks. During these sessions a fasting blood sample will be collected and participants will complete cognitive and mood assessments prior to treatment administration and one hour post administration. At three hours post administration particiapnts will complete cognitive assessment tasks while undergoing an fMRI scan.
Interventions
In the first stage of the study optimised curcumin (400mg) will be taken by 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline) and placebo will be taken for 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline), for a four week period (28 days). A total of 4 treatment groups (cognitive status x treatment) will be included. All treatments are to be taken as one oral capsule per day, with the first treatment administered during baseline testing s
In the first stage of the study optimised curcumin (400mg) will be taken by 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline) and placebo will be taken for 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline), for a four week period (28 days). A total of 4 treatment groups (cognitive status x treatment) will be included. All treatments are to be taken as one oral capsule per day, with the first treatment administered during baseline testing session and final treatment administered during four-week follow-up testing session. A subset of 16 participants, with apparent cognitive decline, will also take part in Stage Two of the study in which treatment dose and duration will be increased (800mg curcumin once daily, for eight weeks) and effect of supplementation on cerebral blood flow will be examined. Stages One and Two will be separated by a wash out period of a minimum of one month.
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)
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female. 2. Aged 65-80 years. 3. Willing and able to provide written informed consent. 4. Understands and is willing and able to comply with all study procedures. 5. Free from history of stroke, other neurological conditions (e.g. Parkinsons, epilepsy), depression, psychiatric disorders, low base line intellect, alcohol abuse past / present. 6. Cognitively healthy participants must be free from any form of cognitive impairment. For the cognitively declined particpants, participants must have objective memory impairment for age and education level. 7. Free from dementia. 8. English speaking. 9. Must have normal or corrected vision. 10. Free from other medical conditions which may affect ability to participate in the study 11. Participants taking part in study Stage Two must be right handed
Exclusion criteria
1. Any significant concurrent illness including any auto-immune disorder, bleeding disorders, heart conditions, diabetes, glaucoma, high blood pressure or osteoporosis. 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 any of the following: anti-coagulant drugs (Warfarin,Heparin, Plavix); anti-cholinergics or acetylcholinesterase inhibitors: bethanechol (Ureholine), donepezil (Aricept), 6. Taking steroid medications 7. Taking vitamins or herbal supplements regularly 8. Left-handed participants will be ineligible to take part in Stage Two
Outcome results
None listed