The effects of a curcumin extract (Curcugen) on energy, mood, and cognitive performance in adults experiencing stress and exhaustio

Not Applicable

Completed

• Conditions: Mood; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Other mental health disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders; Cognitive performance; Energy

• Registration Number: ACTRN12622000528752
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-04
• Study Completion: 2022-12-22
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)[Day 0, week 4, and week 8 (primary endpoint) post-intervention commencement]