Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000528752
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
4/04/2022
Date last updated
14/02/2023
Date data sharing statement initially provided
4/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a curcumin extract (Curcugen) on energy, mood, and cognitive performance in adults experiencing stress and exhaustion
Scientific title
An examination into the effects of a curcumin extract (Curcugen) on energy, mood, and cognitive performance in adults experiencing stress and exhaustion: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 306808 0
None
Universal Trial Number (UTN)
U1111-1276-5769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 325883 0
Energy 325884 0
Mood 325885 0
Condition category
Condition code
Neurological 323191 323191 0 0
Other neurological disorders
Alternative and Complementary Medicine 323192 323192 0 0
Herbal remedies
Mental Health 323193 323193 0 0
Other mental health disorders
Inflammatory and Immune System 323195 323195 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Curcumin extract (Curcugen) (1 capsule taken orally, once daily in the morning or evening with or without food, delivering 250 mg a day for 8 weeks). Adherence to capsule intake will be measured by capsule return at weeks 4 and 8.
Intervention code [1] 323268 0
Treatment: Other
Comparator / control treatment
Placebo (containing maltodextrin) is matched to the curcumin extract capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 330946 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 330946 0
Day 0, week 4, and week 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 408195 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 408195 0
Day 0: Before, 1 and 3hrs post-intervention commencement
Secondary outcome [2] 408196 0
Change in Perceived Stress Scale score
Timepoint [2] 408196 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [3] 408197 0
Everyday Memory Questionnaire – Revised
Timepoint [3] 408197 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [4] 408198 0
Athens Insomnia Scale
Timepoint [4] 408198 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [5] 408199 0
Karolinska Exhaustion Disorder Scale
Timepoint [5] 408199 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [6] 408200 0
Checklist Individual Strength
Timepoint [6] 408200 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [7] 408201 0
Mood assessed by the Bond & Lader Visual Analogue Scale
Timepoint [7] 408201 0
Day 0: Before, 1 and 3hrs post-intervention commencement
Secondary outcome [8] 408202 0
NASA Task Load Index
Timepoint [8] 408202 0
Day 0: Before, 1 and 3hrs post-intervention commencement
Secondary outcome [9] 408203 0
Change in blood concentrations of malondialdehyde
Timepoint [9] 408203 0
Day 0 and week 8 post-intervention commencement
Secondary outcome [10] 408204 0
Change in blood concentrations of brain-derived neurotrophic factor
Timepoint [10] 408204 0
Day 0 and week 8 post-intervention commencement
Secondary outcome [11] 408205 0
Change in blood concentrations of C-reactive protein
Timepoint [11] 408205 0
Day 0 and week 8 post-intervention commencement
Secondary outcome [12] 408206 0
Change in blood concentrations of total antioxidant capacity
Timepoint [12] 408206 0
Day 0 and week 8 post-intervention commencement
Secondary outcome [13] 408207 0
Change in blood concentrations of tumour necrosis factor - alpha
Timepoint [13] 408207 0
Day 0 and week 8 post-intervention commencement
Secondary outcome [14] 408208 0
Change in concentrations of hair cortisol
Timepoint [14] 408208 0
Day 0 and week 8 post-intervention commencement

Eligibility
Key inclusion criteria
1) Healthy individuals (male and female) aged between 40 to 75 years
2) Residing in independent living accommodation
3) Experiencing exhaustion disorder as defined by the criteria set by the Swedish National Board of Health and Welfare (a score greater than or equal to 19 on the Karolinska Exhaustion Disorder Scale)
4) Non-smoker
5) BMI between 18 and 35 kg/m2
6) No plan to commence new treatments over the study period
7) Understand, willing and able to comply with all study procedures
8) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
2) A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
3) Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
4) Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease)
5) History of paralysis, stroke or seizures or head injury (with loss of consciousness).
6) Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antihistamines, benzodiazepines, opioids, or corticosteroids.
7) Change in medication in the last 3 months or expectation to change during the study duration
8) Currently taking curcumin supplements
9) In the last 6 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome
10) Current or 12-month history of illicit drug abuse
11) Alcohol intake greater than 14 standard drinks per week
12) Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
13) Any significant surgeries over the last year
14) Planned major lifestyle change in the next 3 months

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)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 12 randomly permuted blocks, containing 10 participants per block.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous herbal studies, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 36 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. We will be recruiting 40participants per group (80 participants in total). Based on the 80 people recruited, we have a suitable power to find an effect, even after dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
10/10/2022
Actual
24/10/2022
Date of last data collection
Anticipated
12/12/2022
Actual
22/12/2022
Sample size
Target
80
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311144 0
Commercial sector/Industry
Name [1] 311144 0
DolCas Biotech, LLC
Country [1] 311144 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 312491 0
None
Name [1] 312491 0
Address [1] 312491 0
Country [1] 312491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310672 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 310672 0
Ethics committee country [1] 310672 0
Australia
Date submitted for ethics approval [1] 310672 0
15/03/2022
Approval date [1] 310672 0
14/04/2022
Ethics approval number [1] 310672 0
0102E_2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118466 0
Dr Adrian Lopresti
Address 118466 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118466 0
Australia
Phone 118466 0
+61 08 94487376
Fax 118466 0
Email 118466 0
[email protected]
Contact person for public queries
Name 118467 0
Adrian Lopresti
Address 118467 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118467 0
Australia
Phone 118467 0
+61 08 94487376
Fax 118467 0
Email 118467 0
[email protected]
Contact person for scientific queries
Name 118468 0
Adrian Lopresti
Address 118468 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118468 0
Australia
Phone 118468 0
+61 08 94487376
Fax 118468 0
Email 118468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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
No additional documents have been identified.