None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 60 years experiencing high perceived stress will be randomly assigned to receive an Aframomum melegueta seed extract (Vanizem) or a matching placebo for 28 days. Changes in self-reported perceived stress, anxiety, general mood, sleep quality, and fatigue will be assessed over time. Moreover, to examine potential mechanisms of action, changes in heart rate variability as well as blood and salivary markers associated with stress, mood, sleep, and cognitive function will be evaluated.
Interventions
Aframomum melegueta seeds extract (Vanizem) (1 capsule taken orally, once daily, in the morning with food, delivering 100mg a day for 28 days). Adherence to capsule intake will be measured by a count of capsules returned on day 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 60 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females aged 18 to 60 years 2. Experiencing self-reported stress 3. A score between 14 and 26 (inclusive) on the Perceived Stress Scale (PSS) at screening 4. Non-smoker for at least 12 months duration 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. Suffering from a diagnosed medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, adrenal disease, gastrointestinal disease requiring regular use of medications, biliary disease, thyroid disease, cancer/malignancy, renal disease, hepatic disease, endocrine disease, respiratory disease, neurodegenerative disease, or chronic/acute pain condition 2. Past gastrointestinal surgery that may affect the absorption of the investigational product 3. Current diagnosis of a psychiatric disorder, other than mild-to-moderate depression or anxiety symptoms 3. Abnormal blood makers comprising one or more of the following: fasting glucose greater than or equal to 7.0 mmol/L; TSH less than 0.4 mIU/L or greater than 4.0 mIU/L; creatinine greater than or equal to 2 times above laboratory reference range; AST or ALT greater than or equal to 3 times above laboratory reference range; or creatine kinase greater than or equal to 2 times above reference ranges 5. In the last 3 months, the regular intake of any pharmaceutical medication (excluding contraceptive medication or the occasional use of analgesics of not more than twice weekly), or an intention to start during the study period. 6. In the last 3 months, the regular intake of any over-the-counter vitamin or herbal supplement, or an intention to start during the study period. 7. Engaged in night-shift work, irregular shift work, or has experienced circadian rhythm disruption (e.g., jet lag) in the last month. 8. Planned major lifestyle or dietary change during the study duration 9. Alcohol intake greater than 14 standard drinks per week 10. Current or 12-month history of illicit drug abuse 11. Pregnant women, women who are breastfeeding, women who are less than 3 months postpartum, or women who intend to become pregnant during the study period. 12. In the last year, has had surgery that affects general health or daily function, or has a planned surgery in the next 2 months 13. Participation in any other clinical trial in the last month
Outcome results
None listed