ARE YOU STRESSED?

Volunteers are needed to investigate the effects of a herbal supplement on adults aged 18 to 60 years who experience mild to moderate stress.

This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry

Link to Clinical Trial Registry

click here to play a video about the study

about this study

This study is only available for people able to travel to our office in Duncraig, WA 6023

Aframomum melegueta (A. melegueta), a member of the ginger family, is commonly known as grains of paradise, alligator pepper, or melegueta pepper. In West Africa, it is used as a spice in cooking and in traditional African medicine to treat various health conditions. Preclinical studies have demonstrated that A. melegueta has neuroprotective, antidepressant, and anti-stress effects. A small trial conducted in adults with A. melegueta extract (Vanizem®) showed positive effects on self-reported mood and sleep. Therefore, the aim of this study is to investigate the effects of Vanizem® on self-reported stress, general mood, sleep, and fatigue in adults experiencing mild to moderate stress. Furthermore, to help understand how Vanizem® works, changes in blood and saliva markers associated with mood, sleep and brain activity will be examined over time.

If you are a generally healthy adult aged 18 to 60 years who is experiencing stress, we invite you to participate in this randomised, controlled study. 

PLEASE NOTE: Travel to our office in Duncraig is required on TWO occasions

what does participating in this study involve?

Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:

  1. Daily intake of capsules containing Vanizem®, or
  2. Daily intake of placebo (fake) capsules 

This 4-week study consists of the following:

  1. Participate in a 10-minute phone interview to discuss the study and assess your eligibility to participate.
  2. Visit our office (located in Duncraig, Western Australia) on 2 occasions (days 0 and 28). During these in-person visits (approximately 60 minutes), you will have a blood sample collected, complete questionnaires, and undergo measurements of your weight, height, blood pressure, and heart rate.
  3. Collect a saliva sample (at home)
  4. Take 1 capsule once daily for 28 days
  5. Complete a daily mood/sleep record (takes less than 1 minute) and online questionnaires at days 3, 7, and 14 (takes 5 to 10 minutes)

You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage

Do I get paid to participate in this study?

To compensate you for your time and travel involved in this study, you will receive a $30 gift voucher on visit 1 and a $150 gift voucher on visit 2. Participants in the placebo group will also receive a complimentary 28-day supply of Vanizem capsules upon completion of this study.

what is the criteria for participating in this study?

To be INCLUDED in the study, the following inclusion criteria must be met:

  1. You are aged 18 to 60 years
  2. You are experiencing self-reported stress and score within the range required on our questionnaire.
  3. You have been a non-smoker for at least 12 months
  4. You have a body mass index between 18 and 35 kg/m2
  5. You have no plan to commence new treatments over the study period.
  6. You understand, are willing and able to comply with all study procedures.
  7. You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:

  1. You have a diagnosis of a 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. You have had a past gastrointestinal surgery that may affect the absorption of the investigational product
  3. You have a current diagnosis of a psychiatric disorder, other than mild-to-moderate depression or anxiety symptoms
  4. You have abnormal blood makers, including fasting glucose, thyroid function, liver function, or renal function.
  5. In the last 3 months, you have regularly taken any pharmaceutical medication (excluding contraceptive medication or the occasional use of analgesics of not more than twice weekly) or intend to start during the study period.
  6. In the last 3 months, you have regularly taken any over-the-counter vitamin or herbal supplement, or intend to start during the study period.
  7. You are engaged in night-shift work, irregular shift work, or have experienced circadian rhythm disruption (e.g., jet lag) in the last month.
  8. You are planning a major lifestyle or dietary change during the study duration
  9. You have an alcohol intake greater than 14 standard drinks per week
  10. You have a current or 12-month history of regular illicit drug use
  11. You are pregnant, breastfeeding, are less than 3 months postpartum, or intend to become pregnant during the study period.
  12. In the last year, you have had surgery that continues to affect your general health or daily function, or have a planned surgery in the next 2 months
  13. You have participated in any other clinical trial in the last month

has this study received ethics approval?

This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0165E_2026)

how can i apply for this study?

If you are interested in participating in this study, please click on the button "Complete the Study Application Form" located on this webpage. This questionnaire will take aproximately 10 minutes to complete and helps us assess your eligibility to participate in this study.

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

can i speak to a researcher to get more information?

If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376

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