Research on Effect of Curcumin in Older Adults – Response to Varying Doses (RECORD Study)

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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. CONDITION: Inflammation; ; Inflammation Inflammatory and Immune System ‐ Normal development and function of the immune system PRIMARY OUTCOME: 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.[All timepoints are essential (baseline, 1, 2, 3, 6, and 24 hours) for area under the curve analyses. ] SECONDARY OUTCOME: 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. [All timepoints are essential (baseline, 1, 2, 3, 6, and 24 hours) for area under the curve analyses.] 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.
Epistemonikos ID: 070101e022a1c51175902df17091ae7c8cbcfe01
First added on: Aug 25, 2024