A randomised double-blind placebo-controlled study to evaluate the effect of curcumin on BDNF levels in otherwise healthy adults.
RDC Global Pty Ltd
70 participants
Mar 3, 2021
Interventional
Conditions
Summary
A randomised double-blind placebo-controlled study to evaluate the effect of curcumin on BDNF levels in otherwise healthy adults. The aim of this study is to assess the effectiveness of a bioavailable form of curcumin on BDNF levels compared to a placebo in otherwise healthy adults aged between 18 and 40 years old.
Eligibility
Inclusion Criteria3
- 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 Criteria15
- 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.
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Interventions
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
Locations(1)
View Full Details on ANZCTR
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ACTRN12621000104853