None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 generally healthy adults aged 18 to 65 experiencing high stress will be randomly assigned to receive an ashwagandha extract (NRAHG001) or a placebo for 28 days. Changes in self-reported stress, mood and fatigue will be measured over time. Moreover, changes in the stress response using subjective and physiological measures after exposure to an experimental stress procedure (Socially Evaluated Cold-Pressor Test) will be investigated. The effects of ashwagandha supplementation on metabolomic markers will also be investigated to help understand the mechanism of action associated with ashwagandha supplementation. It is hypothesised that ashwagandha will be associated with a reduction in self-reported stress, and improvments in overall mood and fatigue.
Interventions
Ashwagandha extract (NRAHG001) (1 capsule taken orally, once daily in the morning with or without food, delivering 30mg for 4 weeks). Adherence to capsule intake will be measured by capsule return at day 7 and 28.
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
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults (male and female) aged between 18 and 65 years 2. Experiencing high self-reported perceived stress as indicated by a score between 8 and 16 on the DASS-21 stress subscale 3. Non-smoker 4. Body mass index (BMI) between 18 and 35 kg/m2 5. No plan to commence new treatments over the study period. 6. Understand, willing and able to comply with all study procedures. 7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/ malignancy. 2. Diagnosis of medical or psychiatric conditions including but not limited to a psychiatric disorder (other than mild-to-moderate depression or anxiety) and/or neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury) 3. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants. 4. Change in medication in the last 3 months or an expectation to change during the study duration. 5. Current use of supplements that contain ashwagandha or other supplements that may affect treatment outcomes. 6. In the last month, commenced or changed the dose of nutritional and/or herbal supplements that may impact treatment outcomes. 7. Planned major lifestyle change in the next 2 months. 8. Alcohol intake greater than 14 standard drinks per week 9. Current (or in the last 12 months) have regularly used illicit drugs 10. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period. 11. Any significant surgeries over the last year 12. Participation in any other clinical trial in the month
Outcome results
None listed