None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 recreationally-active adults will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 6 weeks. We will assess change in exercise enjoyment, mood, and quality of life via several validated self-report measures (to be completed fortnightly). We will also examine change in sleep quality, heart rate variability, and resting heart rate using a wrist-word device (WHOOP strap) that will be worn for 6 weeks. Change in blood concentrations of brain-derived neurotrophic factor, oxytocin, and neuropeptide Y will also be assessed.
Interventions
Condition 1: Placebo tablets (1 tablet taken orally, twice daily for 6 weeks)
Condition 2: Saffron extract (affron) (1 tablet taken orally, twice daily, delivering 28mg a day, for 6 weeks)
Adherence to tablet intake will be monitored through a mobile phone app and tablet return and count.
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
Yes
Inclusion criteria
1. Healthy adults (male and female) 18 to 65 years 2. Engaging in non-professional, moderate-to-intensive aerobic exercise greater than 3 times per week comprising the following activities: running, cycling, swimming, tennis, aerobics, boxing 3. Exercise sessions are greater than 45 minutes and commenced more than 6 months ago 4. Engage in moderate-to-intensive aerobic exercise no more than 14 hrs a week 5. Non-smoker 6. BMI between 18 and 30 kg/m2 7. No plan to commence new treatments over the study period 8. Understand, willing and able to comply with all study procedures 9. 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, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition 2. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy 3. Regular medication intake including but not limited to anticoagulants and anti-hypertensive drugs, anticholinergics, acetylcholinesterase inhibitors, or steroid medications. 4. Change in medication in the last 3 months or an expectation to change during the study duration 5. Currently experiencing significant injuries that may affect the ability to engage in exercise 6. Taking vitamins, herbal, or other nutritional supplements that are reasonably expected to influence study measures. 7. Current or 12-month history of illicit drug abuse 8. Alcohol intake greater than 14 standard drinks per week 9. Consume more than 3 cups a day of coffee (or other caffeinated beverage). 10. Any significant surgeries over the last year 11. Planned major lifestyle change in the next 8 weeks
Outcome results
None listed