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Trial registered on ANZCTR


Registration number
ACTRN12616000484448
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
13/04/2016
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health.
Scientific title
Investigation of the Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health in healthy older adults
Secondary ID [1] 288961 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function
298338 0
Psychological wellbeing (mood, stress fatigue, sleep) 298352 0
Cardiovascular function 298353 0
Brain function (fMRI) 298354 0
Inflammation 298355 0
Oxidative Stress 298356 0
Condition category
Condition code
Mental Health 298453 298453 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 298454 298454 0 0
Herbal remedies
Neurological 298465 298465 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 294441 0
Treatment: Other
Comparator / control treatment
Placebo containing no active ingredients, matched for appearance, taste and smell to active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 297943 0
Cognitive function as measured by:
- Divided Attention Memory and Tracking Task (difference between focused and divided attention task phases in number of correctly recalled words and tracking deficit)
- Virtual morris water maze task (learning as represented by decrease in escape latency/path, and memory as represented by escape latency/path in immediate and delayed probe trials)
- Serial 3 & serial 7 subtraction (number of correct responses in 2 minutes)
- Behavioural Pattern Separation Task ( pattern separation deficit)
Timepoint [1] 297943 0
Baseline and 4 and 12 weeks after commencement of intervention
Primary outcome [2] 297944 0
Resistance to negative mood effects of cognitive challenge.
- computerised Bond-Lader visual analogue scales and custom visual analogue scales
- appraisal of cognitive battery as measured by the NASA task load index
Timepoint [2] 297944 0
Baseline and 4 and 12 weeks after commencement of intervention
Primary outcome [3] 297957 0
Mood and well-being - Fatigue
- score on Chalder Fatigue Scale
Timepoint [3] 297957 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [1] 322688 0
Mood and well-being - Psychiatric Health
- General Health Questionnaire (GHQ-28)
Timepoint [1] 322688 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [2] 322689 0
Mood and well-being - General Mood
- Profile of Mood States (POMS)
Timepoint [2] 322689 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [3] 322690 0
Mood and well-being - Stress
- score on Perceived Stress Inventory (PSS)
Timepoint [3] 322690 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [4] 322691 0
Mood and well-being - Sleep
- Pittsburgh Sleep Quality Index (PSQI)
Timepoint [4] 322691 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [5] 322766 0
Cardiovascular function - Arterial Stiffness
- pulse wave analysis (including blood pressure) using the SphygmoCor system
Timepoint [5] 322766 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [6] 322767 0
Cardiovascular function - Endothelial function
- ultrasound assessment of flow mediated dilation of the brachial atery
Timepoint [6] 322767 0
Baseline and 4 and 12 weeks after commencement of intervention
Secondary outcome [7] 322768 0
Blood biomarkers of health - Inflammation
-cytokines and CRP in serum
- ESR
Timepoint [7] 322768 0
Baseline and 12 weeks after commencing intervention
Secondary outcome [8] 322771 0
Blood biomarkers of health - Oxidative stress
- 8-OHdG and malondialdehyde
- total antioxidant capacity
Timepoint [8] 322771 0
Baseline and 12 weeks after commencing intervention
Secondary outcome [9] 322772 0
Blood biomarkers - Beta amyloid status
- AB40, AB42, BACE
Timepoint [9] 322772 0
Baseline and 12 weeks after commencing intervention
Secondary outcome [10] 322774 0
Blood biomarkers - neurogenesis
- BDNF
Timepoint [10] 322774 0
Baseline and 12 weeks after commencing intervention
Secondary outcome [11] 322775 0
EXPLORATORY OUTCOME: fMRI assessment of brain function
(random sub group of 40 participants, 20 active & 20 placebo)
- BOLD during pattern separation task performance
- cerebral metabolism of oxygen metabolism and blood flow
- MRS

Timepoint [11] 322775 0
Baseline and 12 weeks after commencing intervention
Secondary outcome [12] 322776 0
EXPLORATORY OUTCOME: Pharmacogenomics
Buccal cell samples collected by swab and analysed by the Illumina Infinium instrument.
The relationship between polymorphisms for genes related to curcuminoid pharmacokinetics and pharmacodynamics, and the effect of treatment on primary and secondary outcome measures will be explored.
Timepoint [12] 322776 0
Samples collected as Baseline.
Influence of genetic make up on treatment effects observed at 12 weeks after commencing intervention, will be explored.

Eligibility
Key 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
Minimum age
50 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment bottles identified only by participant/treatment number. Randomisation conducted by personnel who had no other involvement in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power analysis was conducted based on the average effect size (cohen's d = .640) of significant effects observed in a previous trial with identical treatment in similar population. It was determined that a sample size of 78-79 participants was sufficient to achieve 80% power at p = 0.05.

Efficacy data from the 12 week-post commencement of intervention assessment will be analysed by ANCOVA covarying for baseline assessment..

In a secondary analysis this model will also be performed with data from the 4 week-post commencement of intervention assessment.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293313 0
Commercial sector/Industry
Name [1] 293313 0
Verdure Sciences Inc.
Address [1] 293313 0
1250 E. Conner Street
Noblesville, IN 46060
USA
Country [1] 293313 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology, Centre for Human Psychopharmacology
Address
427-451 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 292127 0
None
Name [1] 292127 0
Address [1] 292127 0
Country [1] 292127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294788 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 294788 0
427-451 Burwood Rd, Hawthorn, VIC, 3122
Ethics committee country [1] 294788 0
Australia
Date submitted for ethics approval [1] 294788 0
14/01/2016
Approval date [1] 294788 0
29/02/2016
Ethics approval number [1] 294788 0
SHR 2016/008

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65054 0
Prof Andrew Scholey
Address 65054 0
The Centre for Human Psychopharmacology, Swinburne University of Technology
PO Box 218 (H24)
Hawthorn VIC 3122
Country 65054 0
Australia
Phone 65054 0
+61 3 9214 8932
Fax 65054 0
Email 65054 0
ascholey@swin.edu.au
Contact person for public queries
Name 65055 0
Miss Kate Cox
Address 65055 0
The Centre for Human Psychopharmacology, Swinburne University of Technology
PO Box 218 (H99)
Hawthorn VIC 3122
Country 65055 0
Australia
Phone 65055 0
+61 3 9214 8168
Fax 65055 0
Email 65055 0
kcox@swin.edu.au
Contact person for scientific queries
Name 65056 0
Prof Andrew Scholey
Address 65056 0
The Centre for Human Psychopharmacology, Swinburne University of Technology
PO Box 218 (H24)
Hawthorn VIC 3122
Country 65056 0
Australia
Phone 65056 0
+61 3 9214 8168
Fax 65056 0
Email 65056 0
ascholey@swin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary