This study is investigating the absorption and effectiveness of a natural melatonin product derived from pistachios compared to an existing melatonin product.

Most melatonin products available on the market are made synthetically.   The new melatonin product we are investigating is a natural melatonin product made from pistachio extract. This product offers an alternative to synthetic melatonin.

It is hypothesised that the naturally derived melatonin and the synthetic melatonin will be equivalent in their absorption and impact on sleep quality.

We are investigating a natural food derived melatonin product made from pistachio extract.  This product is being compared to a synthetic melatonin product.

As well as being comparator controlled, this study is also a crossover design.  This means that each person in the study will take the investigational melatonin product as well as the comparator melatonin product. 

Upon enrolment, you will be randomly allocated to one of 2 Product Groups.

• Product Group A participants will receive the natural melatonin product first, then the comparator.
• Product Group B participants will receive the comparator first, then the natural melatonin product.

Each product is taken for a period of 1 week, with a washout period in between. The product order is allocated randomly on a chance basis. Neither you nor the investigators will know which group you are in and what order the products will be allocated to you. This is to ensure that no unintentional bias can impact the results.

The study product will be a provided as a chewable gummy to be taken once daily before bed.

If you are interested in joining the study, you will be invited to start the screening process. This process involves answering a series of questions over the phone so that we can check your suitability against the inclusion and exclusion criteria.

If it looks as though you will be a suitable participant, you will be asked to attend our clinic so that we can finalise your eligibility and enrolment. This short clinic visit will involve checking your body measurements (for BMI calculation) and your vital signs (blood pressure, heart rate, temperature, oxygen saturation).

Once enrolled, many of the study requirements can be completed at home, such as taking the allocated product and completing a daily sleep diary. As part of the study, you will also be required to attend our clinic in Fortitude Valley 2 times during the study.

During the 2 x full day clinic visits (approximately 9 hours each) we will be measuring the absorption of the melatonin product in your blood. To do this, multiple blood samples will be taken over the course of the day. But do not worry about multiple needle pricks, we will insert a cannula in your arm at the start of the day (a small flexible tube) which will be used to draw the blood.

The 2 clinic visits will run from approximately 7.30am until 4.30pm. You will return home in the afternoon, there are no overnight stays required for this study.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

You will be participating in this study for approximately 4 weeks.  There is also a short screening period prior to enrolment. 

You will be required to attend our clinic for 3 visits throughout the study. The visit schedule is as follows:

• Visit 1: approximately 30 minutes (screening and enrolment)
• Visit 2: approximately 9 hours (first product absorption day)
• Visit 3: approximately 9 hours (second product absorption day)

We will be recruiting 20 people into this study who will attend our clinic in smaller Clinic Groups of around 5 people. Each Clinic Group will attend our clinic on the same dates (per below). The dates currently available for enrolment are:

Group 1

Before Nov 1st – Visit 1: Attend a brief screening and enrolment appointment 

Nov 2nd to 4th – Complete 1st Baseline sleep diary at home

Nov 5th – Visit 2 : Attend first full day in-clinic

Nov 6th to 12th – Take 1st study product each evening, complete sleep diary on the following mornings at home

Nov 13th to 25th – Washout period

Nov 23rd to 25th – Complete 2nd Baseline sleep diary at home

Nov 26th – Visit 3 : Attend second full day in-clinic 

Nov 27th to Dec 3rd  -Take 2nd study product each evening, complete sleep diary following mornings at home

Dec 4th – 10th – Complete phone exit interview and return sleep diary (post or drop off)

Group 2

Before Nov 3rd – Visit 1: Attend a brief screening and enrolment appointment

Nov 4th to 6th – Complete 1st Baseline sleep diary at home

Nov 7th – Visit 2 : Attend first full day in-clinic

Nov 8th to 14th – Take 1st study product each evening, complete sleep diary on the following mornings at home

Nov 15th to 27th – Washout period

Nov 25th to 27th – Complete 2nd Baseline sleep diary at home

Nov 28th – Visit 3 : Attend second full day in-clinic

Nov 29th to Dec 5th – Take 2nd study product each evening, complete sleep diary following mornings at home

Dec 6th to 12th – Complete phone exit interview and return sleep diary (post or drop off)

You will be asked at the time of screening to nominate your preferred Clinic Group and confirm that you will be available on those dates.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

You will be eligible for a $500 reimbursement for your time and travel expenses once all study requirements have been met. Pro rata payments are also available in the case of early withdrawal or for your time in attending the in clinic blood pressure screening.

Payment will be made via direct deposit to your nominated bank account, or you can choose to receive gift cards to the same value. Payment will be issued once, at the conclusion of your involvement in the study.

• Screening Visit: $50
• Conclusion of 1^st supplementation period and assessments: $200
• Conclusion of 2^nd supplementation period and assessments: $250

If you are interested in participating, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

Our clinic is located on Level 3, 252 St Pauls Terrace, Fortitude Valley. 

 Getting to Us

• Private Transport: limited paid street parking is available in the nearby streets
• Train: Fortitude Valley Train Station (350m away)
• Bus: multiple bus stops within close proximity

• Regularly experience difficulty getting to sleep
• Adults over 18 years
• Generally healthy with no uncontrolled or serious illnesses
• BMI 18.5 – 29.9kg/m² (you can check this on the BMI calculator below)
• Agree to not change current diet and/or exercise frequency or intensity during entire study period
• Able to provide informed consent
• Able to commit to completing the study requirements

Please register your interest by answering the registration questionnaire and completing the form on this page, we’ll then get in touch to screen you for suitability.

Body Mass Index (BMI) Calculator

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.

This RDC Clinical study has been approved by the University of Queensland Human Research Ethics Committee under Approval Number: 2024/HE001744. The study is also registered on the clinicaltrials.gov under Registration Number: (insert number).

Trained trial coordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.