Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001027808
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
24/09/2012
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the Acute and Chronic Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health in an Elderly Population.
Scientific title
Investigation into the Acute and Chronic Effects of Longvida Curcumin on Cognitive Function, Mood and Biomarkers of Health in a Cognitively Healthy Elderly Population Compared to an Elderly Population with Cognitive Decline
Secondary ID [1] 281260 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 287453 0
Cerebral Blood Flow (fMRI) 287455 0
Inflamation 287456 0
Oxidative stress 287457 0
Mood, stress and fatigue 287468 0
Condition category
Condition code
Mental Health 287794 287794 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 287800 287800 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285735 0
Prevention
Intervention code [2] 285736 0
Treatment: Other
Comparator / control treatment
Placebo, is matched to to the curcumin capsules in terms of taste and appearance, but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 288016 0
Cognitive performance - performance on the following Computerised Mental Performance Assessment System (COMPASS) tasks: immediate and delayed word recall, delay word recognition, delayed picture recognition, simple reaction time, choice reaction time, digit vigilance, rapid visual information processing (Bakan) task and Serial subtraction (3s and 7s)
Timepoint [1] 288016 0
Stage One - Baseline and four weeks, assessed immediately prior to dose administration, 1 hour post administration and 3 hours post administration.
Stage Two - Baseline and eight weeks, assessed immediately prior to dose administration and 1 hour post administration.
Primary outcome [2] 288017 0
Mood and anxiety assessments:
Chronic mood - General Health Questionnaire, Chalder Fatigue Scale, Depression, Anxiety and Stress Scale (DASS)

Acute/State Mood - State-Trait Anxiety Inventory (STAI) state scale, Bond-Lader Visual Analogue Scales, stress and fatigue visual analogue mood scales.
Timepoint [2] 288017 0
Stage One - Baseline and four weeks
- Chronic mood assessed pre-dose
- Acute/State mood assessed immediately prior to dose administration, 1 hour post administration and 3 hours post administration

Stage Two - Baseline and eight weeks
- Chronic mood assessed pre-dose
- Acute/State mood assessed immediately prior to dose administration and 1 hour post administration
Secondary outcome [1] 299288 0
Blood biomarkers:
blood lipids (LDL, HDL, triglycerides, total cholesterol),
C-reactive protein (CRP),
fibrinogen
inflammatory cytokines IL1B and IL6
amyloid-beta 40 and 42,
telomere length,
SIRT-1 expression
Timepoint [1] 299288 0
Stage One - Baseline and four weeks
Stage Two - Baseline and eight weeks

At all visits this will be assesses in a fasting blood sample, prior to dose administration.
Secondary outcome [2] 299289 0
fMRI brain imaging and performance on rapid visual information processing and inspection time tasks completed during scan.
Timepoint [2] 299289 0
Stage Two - Baseline and eight weeks, assessed at 3 hours post dose administration.

Eligibility
Key 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
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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)
Participants will respond to advertisements and pass a telephone screening interview before coming in for their screening and enrollment session. Participants will be allocated the next available sequential identification number which will correspond to a treatment number. Treatment numbers will be randomly allocated to curcumin or placebo using a computerised random number generator.
The research/s who determines if a participant is eligible for inclusion in the trial will be unaware, when this decision was made, to which treatment group the participant will be be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will perform the randomisation sequence using a computerised random number generator. Randomisation will be carried out separately for healthy and cognitively declined groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a placebo-controlled, double-blind, randomised, single centre parallel groups study examining the acute and chronic effects of curcumin supplmentation in inviduals who are cognitive healthy or show evidence of cognitive decline. The effects of acute supplementation following chronic administration will also be investigated.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286035 0
Commercial sector/Industry
Name [1] 286035 0
Verdure Sciences Ltd
Country [1] 286035 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] 284847 0
None
Name [1] 284847 0
Address [1] 284847 0
Country [1] 284847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288083 0
Swinburne University Human research Ethics Committee
Ethics committee address [1] 288083 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 288083 0
Australia
Date submitted for ethics approval [1] 288083 0
Approval date [1] 288083 0
07/09/2012
Ethics approval number [1] 288083 0
SUHREC 2012/163

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34735 0
Address 34735 0
Country 34735 0
Phone 34735 0
Fax 34735 0
Email 34735 0
Contact person for public queries
Name 17982 0
Kate Cox
Address 17982 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H99, PO BOX 218
Hawthorn Vic, 3122
Country 17982 0
Australia
Phone 17982 0
+61 03 9214 8168
Fax 17982 0
Email 17982 0
[email protected]
Contact person for scientific queries
Name 8910 0
Prof. Andrew Scholey
Address 8910 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24, PO BOX 218
Hawthorn Vic, 3122
Country 8910 0
Australia
Phone 8910 0
+61 03 9214 8932
Fax 8910 0
Email 8910 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIExamining the potential clinical value of curcumin in the prevention and diagnosis of Alzheimer’s disease2015https://doi.org/10.1017/s0007114515004687
N.B. These documents automatically identified may not have been verified by the study sponsor.