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Trial registered on ANZCTR


Registration number
ACTRN12620000868987p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2020
Date registered
31/08/2020
Date last updated
31/08/2020
Date data sharing statement initially provided
31/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing whether a highly absorbable curcumin formulation can decrease inflammation and free radical damage in middle aged participants
Scientific title
Assessment of the effect of a novel curcumin formulation on markers of inflammation and oxidative damage in healthy middle age participants
Secondary ID [1] 301717 0
nil
Universal Trial Number (UTN)
U1111-1254-9414
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subclinical inflammation 318173 0
oxidative damage 318174 0
Inflammatory and immune system 318859 0
Condition category
Condition code
Alternative and Complementary Medicine 316189 316189 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 316863 316863 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of 3 study arms.
Group 1 Placebo (Silicon dioxide, red & yellow food colouring), n=15
Group 2 Novel curcumin formulation using LipiSperse® technology (listed in Therapeutic Goods Administration (TGA) as Hydrocurc; ARTG ID 295857) - 752 mg of curcuminoids equivalent; 376 mg curcuminoids twice daily, before meals, n=15
Group 3 Curcumin without LipiSperse® technology - 752 mg curcumin equivalent; 376 mg curcuminoids twice daily, before meals, n=15

Mode of administration- oral capsule
Duration of study - 8 weeks
Blood samples will be collected for testing at baseline 2, 4, 6 and 8 weeks
Intervention code [1] 318018 0
Treatment: Drugs
Comparator / control treatment
Group 1 Placebo (Silicon dioxide, red & yellow food colouring), n=15"., twice daily before meals
Control group
Placebo

Outcomes
Primary outcome [1] 324369 0
Change in markers of inflammation using cytokine markers: IL-10, IL-6, IFN-g,and TNF-a, the kynurenine to tryptophan ratio and plasma C-reactive protein ( CRP)
Timepoint [1] 324369 0
8 weeks after commencement of treatment
Primary outcome [2] 324370 0
Change in markers of oxidative activity including, analysis of Total antioxidant capacity (TAC) and hydroperoxide in plasma
Timepoint [2] 324370 0
8 weeks after commencement of treatment
Secondary outcome [1] 384466 0
Change in the experience of pain by numerical rating scales
Timepoint [1] 384466 0
8 weeks after commencement of study
Secondary outcome [2] 384467 0
Change in experience of fatigue by Fatigue assessment questionnaire
Timepoint [2] 384467 0
8 weeks after commencement of treatment
Secondary outcome [3] 384468 0
Altered experience of itch assessed by numerical rating scales
Timepoint [3] 384468 0
8 weeks after commencement of treatment
Secondary outcome [4] 384469 0
Altered experience of morning stiffness assessed by Numerical rating Scales
Timepoint [4] 384469 0
8 weeks after initiation of treatment

Eligibility
Key inclusion criteria
Participants recruited into this study will be males and/or females aged between 40 and 60 years who:
• are not currently taking any pharmacotherapies for inflammatory disorders including, rheumatoid arthritis and other autoimmune conditions including, Lupus, MS, Guillian-Barre syndrome, psoriasis etc.
• do not have impaired renal function,
• do not regularly take aspirin, ibuprofen or other anti-inflammatory medications,
• are willing to cease supplementation(e.g. antioxidants, flavonoids, minerals, omega-3 etc) for at least 7 days before the start of this study, and are willing to refrain from taking additional supplements for the duration of the trial,
• have no known sensitivity to turmeric, curcumin or its metabolites, or red/yellow food colouring,
• have an hsCRP between 2.5 – 10.00 µg/mL,
• are not pregnant
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Are currently taking anti-inflammatory medication
- Are cognitively impaired and/or are unable to give informed consent for any reason

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)
numbered containers
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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Associations between variables will be analysed using appropriate statistical methods. Normality tests will be performed for all continuous variables. If the normality of the variables are confirmed the repeated measures ANOVA and one-way ANOVA will be used to test the equality of the means for each selected category. If the variables are not normally distributed, and cannot be transformed, then the nonparametric equivalent will be used. The statistical significance level will be set at 5% (p<0.05). Statistical analyses will be performed using SPSS 24.0 for Windows.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
1/11/2021
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17037 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 30706 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 306155 0
Commercial sector/Industry
Name [1] 306155 0
Pharmako Biotechnologies
Country [1] 306155 0
Australia
Primary sponsor type
Other
Name
Australasian Research Institute
Address
C/- Sydney Adventist Hospital
185 Fox Valley Rd
Wahroonga NSW 2076
Country
Australia
Secondary sponsor category [1] 306625 0
None
Name [1] 306625 0
Address [1] 306625 0
Country [1] 306625 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306371 0
Adventist health Care Ltd Human Research Ethics Committee (AHCHREC)
Ethics committee address [1] 306371 0
Ethics committee country [1] 306371 0
Australia
Date submitted for ethics approval [1] 306371 0
08/07/2020
Approval date [1] 306371 0
Ethics approval number [1] 306371 0

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

Contacts
Principal investigator
Name 103646 0
A/Prof Ross Grant
Address 103646 0
Australasian Research Institute
185 Fox Valley Rd
Wahroonga NSW 2076
Country 103646 0
Australia
Phone 103646 0
+61 2 94879602
Fax 103646 0
61 2 94879626
Email 103646 0
rossg@sah.org.au
Contact person for public queries
Name 103647 0
Heidi Fedorow
Address 103647 0
Australasian Research Institute
185 Fox Valley Rd
Wahroonga, NSW 2076
Country 103647 0
Australia
Phone 103647 0
+61 401 000 781
Fax 103647 0
61 2 94879626
Email 103647 0
hfedorow@bigpond.com
Contact person for scientific queries
Name 103648 0
Ross Grant
Address 103648 0
Australasian Research Institute
185 Fox Valley Rd
Wahroonga NSW 2076
Country 103648 0
Australia
Phone 103648 0
+61 2 94879602
Fax 103648 0
61 2 94879626
Email 103648 0
rossg@sah.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
While no restrictions have been placed on the research regarding publication of data from the trial by the commercial partner in deference to potential commercial sensitivities the trial sponsor has elected not to include IPD.


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.