Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000980831
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Research on Effect of Curcumin in Older Adults – Response to Varying Doses (RECORD Study)
Scientific title
Effect of Curcumin Supplementation at Varying Doses on Inflammatory Markers in Older Male Individuals
Secondary ID [1] 304088 0
None
Universal Trial Number (UTN)
Trial acronym
RECORD Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Inflammation 321931 0
Condition category
Condition code
Inflammatory and Immune System 319655 319655 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The RECORD study is a controlled, double-blind, crossover intervention trial in healthy older males (50-70 years), designed to understand the anti-inflammatory effects of curcumin following supplementation at varying doses. The aim is to assess the effectiveness of curcumin as an anti-inflammatory agent at doses of 100 mg, 250 mg and 500 mg compared to a control group. Participants will consume one-off dose of curcumin (either placebo, 100 mg, 250 mg or 500 mg) orally at each visit in the form of capsules under staff supervision.
Intervention code [1] 320566 0
Treatment: Other
Comparator / control treatment
Control treatment will be a glucose capsule
Control group
Placebo

Outcomes
Primary outcome [1] 327533 0
The primary outcome for this study is to observe changes in inflammatory markers IL-6 and TNF-a in blood plasma following ingestion of curcumin. IL-6 and TNF-a will be measured by ELISA assay from collected blood plasma.
Timepoint [1] 327533 0
All timepoints are essential (baseline, 1, 2, 3, 6, and 24 hours) for area under the curve analyses.
Secondary outcome [1] 395570 0
We will also assess the bioavailability of curcumin at different doses by analysing plasma samples at each time point for curcumin and it's metabolites (dimethylcurcumin and bisdimethylcurcumin) using High Performance Liquid Chromatography – Photo Diode Array (HPLC-PDA) detector. The area under the curve for curcumin and it's metabolites will be used as the composite outcome measure.
Timepoint [1] 395570 0
All timepoints are essential (baseline, 1, 2, 3, 6, and 24 hours) for area under the curve analyses.

Eligibility
Key inclusion criteria
Participants must be healthy males and in the age category of 50-70 years, with a BMI of 18 - 30 kg/m2 and not taking any curcumin supplements (in the last 6 months). They should be non-smokers and available to come to the lab for visits.
Minimum age
50 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they have established gall bladder problems, pacemaker implants, severe neurological diseases or seizures. Based on their medication intake from the medical questionnaire, participants will be excluded from the trial if they are taking any medication for type II diabetes mellitus, hypertension and heart conditions; and curcumin supplements (in the past 6 months) to avoid any possible drug interaction with curcumin.

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 of the participants will be conceal using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be established using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Calculations for subject size were conducted in G*Power and the results gave a sample size of seven for detecting a medium effect.

IBM SPSS software version 26 will be used for statistical analysis of data. Participant characteristics will be presented as means and standard deviation. The data will be checked for normality and constant error variance and data that is in violation of these assumptions will be normalized using a log-transformation and will be represented as means ± standard deviation. If the data fails to normalize median along with 25th and 75th percentiles and non-parametric tests will be used. For normal data, repeated-measures one-way ANOVA will be used to understand the differences within subjects for the inflammatory markers at different doses and varying time intervals. The statistical significance will be set at a level of p<0.05 and post hoc analysis will be conducted for significant outcomes. Effect size (Cohen’s d) and correlation between the dose and the inflammatory markers will be measured. Curcumin and its metabolites will be represented in the form of area under curve and graphs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
24/11/2022
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 23709 0
New Zealand
State/province [1] 23709 0
Auckland

Funding & Sponsors
Funding source category [1] 308472 0
University
Name [1] 308472 0
Massey University
Country [1] 308472 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University, East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 309479 0
None
Name [1] 309479 0
Address [1] 309479 0
Country [1] 309479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308428 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 308428 0
Ethics committee country [1] 308428 0
New Zealand
Date submitted for ethics approval [1] 308428 0
23/10/2020
Approval date [1] 308428 0
26/01/2021
Ethics approval number [1] 308428 0
SOA 20/57

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

Contacts
Principal investigator
Name 110674 0
Ms Krutika Nanavati
Address 110674 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 110674 0
New Zealand
Phone 110674 0
+64211451392
Fax 110674 0
Email 110674 0
[email protected]
Contact person for public queries
Name 110675 0
Krutika Nanavati
Address 110675 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 110675 0
New Zealand
Phone 110675 0
+64211451392
Fax 110675 0
Email 110675 0
[email protected]
Contact person for scientific queries
Name 110676 0
Krutika Nanavati
Address 110676 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 110676 0
New Zealand
Phone 110676 0
+64211451392
Fax 110676 0
Email 110676 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
Trial data will remain anonymised throughout the trial. No external researchers or databases will have access to individual data.


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.