None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 adults experiencing stress-induced exhaustion will be randomly assigned to receive capsules containing either a curcumin extract (Curcugen) (250mg once daily) or a placebo for 8 weeks. We will assess changes in cognitive performance, stress, fatigue, and sleep using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor – a and C-reactive protein), free radical damage (Malondialdehyde and Total Antioxidant Capacity), and Brain-derived neurotrophic factor (important for the survival of brain cells) will be assessed over time. Using hair samples collected at the beginning and end of the study, we will also measure changes in the stress hormone cortisol It is hypothesised that, compared to the placebo, curcumin supplementation will be associated with greater improvements in mood, cognitive performance, energy, and markers of stress, inflammation, and oxidative stress.
Interventions
Curcumin extract (Curcugen) (1 capsule taken orally, once daily in the morning or evening with or without food, delivering 250 mg a day for 8 weeks). Adherence to capsule intake will be measured by capsule return at weeks 4 and 8.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Healthy individuals (male and female) aged between 40 to 75 years 2) Residing in independent living accommodation 3) Experiencing exhaustion disorder as defined by the criteria set by the Swedish National Board of Health and Welfare (a score greater than or equal to 19 on the Karolinska Exhaustion Disorder Scale) 4) Non-smoker 5) BMI between 18 and 35 kg/m2 6) No plan to commence new treatments over the study period 7) Understand, willing and able to comply with all study procedures 8) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1) Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria 2) A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) 3) Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy 4) Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease) 5) History of paralysis, stroke or seizures or head injury (with loss of consciousness). 6) Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antihistamines, benzodiazepines, opioids, or corticosteroids. 7) Change in medication in the last 3 months or expectation to change during the study duration 8) Currently taking curcumin supplements 9) In the last 6 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome 10) Current or 12-month history of illicit drug abuse 11) Alcohol intake greater than 14 standard drinks per week 12) Pregnant women, women who are breastfeeding or women who intended to fall pregnant. 13) Any significant surgeries over the last year 14) Planned major lifestyle change in the next 3 months
Outcome results
None listed