Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000104853
Ethics application status
Approved
Date submitted
1/12/2020
Date registered
2/02/2021
Date last updated
23/02/2022
Date data sharing statement initially provided
2/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised double-blind placebo-controlled study to evaluate the effect of
curcumin on BDNF levels in otherwise healthy adults.
Scientific title
A randomised double-blind placebo-controlled study to evaluate the effect of
curcumin on BDNF levels in otherwise healthy adults.
Secondary ID [1] 302910 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain-Derived Neurotrophic Factor in healthy adults 319923 0
Condition category
Condition code
Neurological 317865 317865 0 0
Studies of the normal brain and nervous system
Alternative and Complementary Medicine 317866 317866 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised double-blind placebo-controlled study with a 6-week participation and 2 groups (1 active ingredient group and 1 inactive placebo group). HydroCurc® is a TGA approved product (ARTG ID 295857) containing the active ingredient Curcumin.

Once enrolled in the study, participants will be randomly allocated to either the placebo group or the active treatment group. An opaque container of capsules will be provided to each participant according to their randomisation. Participants will be instructed to take 2 x 250 mg capsule of HydroCurc [(total containing 450 mg of a curcumin extract (containing 95% or 427 mg of curcuminoids)] daily with water and food for the duration of the study (6 weeks).

Participants will be asked to attend the study site at baseline, at 21 days (mid-point) and 6 weeks (final). At baseline, participants will complete a fasting blood test, general health measurements and health questionnaire. A fasting blood test and health questionnaire will be completed at the study site at 21 days and 6 weeks. At the end of the six weeks, participation in the study will be considered complete.

Adherence will be monitored by product return at completion of 6 weeks of supplementation
Intervention code [1] 319194 0
Treatment: Drugs
Comparator / control treatment
The placebo will be microcrystalline cellulose encapsulated in an opaque vegetable capsule. It will be produced to appear identical to the test product. The placebo will be administered as 2 capsules taken daily for the duration of the study (6 weeks) using the same procedure detailed for the Active product HydroCurc®. The placebo product is to be stored in identical trial product containers at room temperature away from direct sunlight.
Control group
Placebo

Outcomes
Primary outcome [1] 325879 0
Change in serum BDNF concentrations as analysed by serum assay
Timepoint [1] 325879 0
Baseline, 21 days post-intervention commencement (week 3) & Week 6 post-intervention commencement
Secondary outcome [1] 389410 0
Change in inflammatory markers (TNF-a, CRP, IL-6) as measured via serum assay as composite outcome
Timepoint [1] 389410 0
Baseline, 21 days post-intervention commencement (week 3) & week 6 post-intervention commencement
Secondary outcome [2] 389411 0
Change in Quality of life questionnaires (SF-36)
Timepoint [2] 389411 0
Baseline, 21 days post-intervention commencement (week 3) & week 6 post-intervention commencement
Secondary outcome [3] 389412 0
Change in anthropometric measurements (height measured using stadiometer, weight measured using digital scales, hip circumference as measured using measuring tape, waist circumference as measured using measuring tape, BMI) as composite outcome.
Timepoint [3] 389412 0
Baseline, 21 days post-intervention commencement (week 3) & week 6 post-intervention commencement
Secondary outcome [4] 389413 0
Change in pathology markers (E/LFT, Ferritin) as measures by serum assay as composite outcome
Timepoint [4] 389413 0
Baseline, 21 days post-intervention commencement (week 3) & week 6 post-intervention commencement
Secondary outcome [5] 389414 0
Product tolerance as measured by targeted gastrointestinal questions designed for the study
Timepoint [5] 389414 0
Week 6 post-intervention commencement
Secondary outcome [6] 391262 0
Change in blood pressure measured with automatic blood pressure machine
Timepoint [6] 391262 0
Baseline, 21 days post-intervention commencement (week 3) & week 6 post-intervention commencement

Eligibility
Key inclusion criteria
• Male and females aged 18-40 years old
• Able to provide informed consent
• Agree not to take other supplements (e.g. curcumin, iron, resveratrol, fish oil) that may affect BDNF for the duration of the trial and within 2 weeks prior to commencing the study
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Iron deficient anaemia
• Unstable or serious illness (e.g. kidney, liver, biliary, GIT, heart conditions, diabetes, thyroid gland function, malignancy, lung conditions, chronic asthma, mood disorders or neurological disorders such as MS)*
• Currently taking medications that may affect BDNF such as antidepressants or anxiety medications, or have taken within the previous 6 months
• Prescribed/receiving anticoagulation therapy (e.g., coumadin, heparin)
• Females who are either trying to conceive, pregnant or lactating
• Any chronic menstrual disorders or menopausal changes
• Alcohol consumption exceeding 21 drinks/week
• Active smoker/e-cigarettes/nicotine use, use recreational drugs
• Any chronic gastrointestinal problems
• History of eating disorders
• Serious mood disorder
• Hypotensive (blood pressure less than 90mm/60mmHg) or hypertensive (blood pressure greater or equal to 140/90mmHg)
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other related clinical study during the past 1 month

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2021
Actual
3/03/2021
Date of last participant enrolment
Anticipated
Actual
23/06/2021
Date of last data collection
Anticipated
Actual
26/07/2021
Sample size
Target
70
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307330 0
Commercial sector/Industry
Name [1] 307330 0
Pharmako Biotechnologies Pty Ltd
Country [1] 307330 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 307970 0
Commercial sector/Industry
Name [1] 307970 0
Pharmako Biotechnologies Pty Ltd
Address [1] 307970 0
36 Campbell Ave, Cromer NSW 2099
Country [1] 307970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307419 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 307419 0
Ethics committee country [1] 307419 0
Australia
Date submitted for ethics approval [1] 307419 0
22/09/2020
Approval date [1] 307419 0
02/12/2020
Ethics approval number [1] 307419 0

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

Contacts
Principal investigator
Name 107174 0
Dr David Briskey
Address 107174 0
RDC Global Pty Ltd
3B/76 Doggett St, Newstead, QLD, 4006
Country 107174 0
Australia
Phone 107174 0
+61 421 784 077
Fax 107174 0
Email 107174 0
[email protected]
Contact person for public queries
Name 107175 0
Amanda Rao
Address 107175 0
RDC Global Pty Ltd
3B/76 Doggett St, Newstead, QLD, 4006
Country 107175 0
Australia
Phone 107175 0
+61 414 488 559
Fax 107175 0
Email 107175 0
[email protected]
Contact person for scientific queries
Name 107176 0
Amanda Rao
Address 107176 0
RDC Global Pty Ltd
3B/76 Doggett St, Newstead, QLD, 4006
Country 107176 0
Australia
Phone 107176 0
+61 414 488 559
Fax 107176 0
Email 107176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


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.