None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults experiencing high stress and sleep difficulties will be randomly assigned to receive capsules containing either an Ocimum tenuiflorum (Holy Basil) extract (125 mg twice daily) or a placebo for 8 weeks. We will assess change in stress levels, general mood, sleep quality, and quality of life via several validated self-report measures. We will also examine change in sleep quality and resting heart rate using a wrist-word device (Fitbit) that will be worn for 8 weeks. Group differences in hair cortisol concentrations collected at week 8 will also be examined. At week 8, participants will be exposed to an experimental stress procedure known as the Maastricht Acute Stress Test (MAST). We will assess group differences in salivary cortisol, a-amylase, blood pressure, pulse rate, and mood ratings during and after this procedure.
Interventions
Condition 1: Placebo capsules (2 capsules taken orally, twice daily with breakfast and dinner for 8 weeks)
Condition 2: Ocimum tenuiflorum (Holy Basil) extract (2 capsules taken orally, twice daily with breakfast and dinner, delivering 250 mg a day for 8 weeks)
Adherence to capsule intake will be monitored through a mobile phone app and capsule 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
No
Inclusion criteria
1. Adults aged 18-65 years of age 2. Body mass index between 18.5 kg/m2 and 30 kg/m2 3. Currently experiencing high stress (as determined by a Perceived Stress Scale score of 14 or higher) 4. Stressor or anxiety has been present for greater than a month 5. Self-reported sleep difficulties (as determined by a rating of 3 or higher on at least one of the first 5 questions of the Insomnia Symptom Questionnaire) 6. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pill are permissible. 7. Non-smoker 8. No plan to commence new treatments over the study period 9. Willing to wear a Fitbit to bed for the duration of the study 10. Willing to provide a personally-signed informed consent form detailing all pertinent aspects of the trial. 11. Willing and able to take prescribed capsules for 8 weeks
Exclusion criteria
1. Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status 2. Participation in another clinical trial within 30 days before screening 3. Suffer from mental-health disorder other than mild depressive or anxiety symptoms as measured by Patient Health Questionnaire-4 4. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/ gallstones/ biliary disease, autoimmune disease, endocrine disease, and acute or chronic pain condition 5. Alcohol consumption greater than 14 standard drinks per week 6. Current or 12-month history of illicit drug abuse 7. Caffeine intake greater than 4 cups a day 8. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant. 9. Currently taking supplements that may impact on treatment outcome
Outcome results
None listed