A randomised double-blind placebo-controlled study to evaluate the effect ofcurcumin on BDNF levels in otherwise healthy adults.

Phase 3

Completed

• Conditions: Brain-Derived Neurotrophic Factor in healthy adults; Neurological - Studies of the normal brain and nervous system; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12621000104853
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Study Completion: 2021-07-26
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum BDNF concentrations as analysed by serum assay [Baseline, 21 days post-intervention commencement (week 3) & Week 6 post-intervention commencement ]