ActivePhase 3Phase 4ACTRN12616000484448

Investigation of the Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health.

Investigation of the Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health in healthy older adults

Sponsor

Swinburne University of Technology, Centre for Human Psychopharmacology

Enrollment

80 participants

Start Date

Jun 14, 2016

Study Type

Interventional

Conditions

Brain function (fMRI)Psychological wellbeing (mood, stress fatigue, sleep)Inflammation Oxidative Stress Cardiovascular function

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.

Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 85 Yearss

Inclusion Criteria9

Aged 50-85 years.
Willing and able to provide written informed consent.
Understand and willing and able to comply with all study procedures.
No history of stroke, neurological conditions (e.g. Parkinson’s, epilepsy), depression, psychiatric disorders, low base line intellect, alcohol abuse past / present.
Free from dementia.
Fluent in written and spoken English.
Must have normal or corrected vision and not colour blind.
Free from medical conditions which may affect ability to participate in the study
Participants taking part in the MRI sub-study must be right handed

Exclusion Criteria8

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.
Any known or suspected food allergies
Smokers and users of recreational drugs (except alcohol and other food grade actives).
Have participated in any other study involving an investigational product in the last 4 weeks.
Taking anti-coagulant drugs or anti-cholinergics or acetylcholinesterase inhibitors.
Taking steroid medications.
Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
Left-handed participants will be ineligible to take part in the MRI sub-study.

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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 co

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).