NEW STUDY ANNOUNCEMENT

PeptiSleep Study

Not getting enough sleep?
We are seeking adults 18-65 years who experience mild to moderate sleep issues to help assess a brown rice derived product.

Thank you for your interest in our sleep study where we are assessing the tolerability and efficacy of a new product derived from brown rice protein being developed to improve sleep quality.

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.

How long is the study, and when does it start?

Your involvement in this study will be required for 10 weeks, 8 of which you will be required to take the study product. We are recruiting on a rolling basis which means that your individual start date is flexible.

For your convenience, our RDC Clinic is open Monday to Saturday from 6.30am.

Please see below for more information. You can also register your interest using the form at the bottom of this page.

About the product you’ll help investigate…

This study is designed to examine the effects of a food supplement called PeptiSleep in people with mild to moderate sleep issues. PeptiSleep is a natural, plant-based supplement made from hydrolysed brown rice ((Oryza sativa) protein. The supplement contains bioactive peptides which may relieve stress and promote healthier sleep.

PeptiSleep is a supplement made from the targeted hydrolysis of brown rice. The hydrolysis process releases bioactive peptides which have shown activity of mechanisms associated with sleep and stress. These peptides cannot be released by simply eating brown rice, this is part of the novelty of this approach. Importantly, and unlike other sleep aids, the mechanisms are non-addictive. PeptiSleep is vegetarian friendly and has not been tested on animals.

The product will be supplied in capsule form, and participants will be asked to take the product 1 hour before bed each evening for 8 weeks.

As this study is placebo-controlled, you may or may not be allocated the active product. The product is allocated randomly on a chance basis, and you will not know which product group you have been allocated to. This is to ensure that no unintentional bias can impact the results.

In this study, there are 3 active groups and 1 placebo group, so you will have a 75% chance of receiving the active product.

Placebos are designed to look like the real product being studied except they do not contain the active ingredient. Using a placebo helps us to be confident that any effects we measure in the active group really are due to the active ingredient and not due to the body’s own reaction to a perceived treatment.

Why is this study being conducted?

Sleep health – quality and quantity – is important for our overall health and well-being. Sleep can be affected by many factors and sleep impairment can have negative impacts on our general health and quality of life.

Those who suffer from poor sleep often turn to aids to assist and improve their sleeping habits. These can include prescription and over the counter medications, sleep aids, or herbal supplements. Whilst these may be effective in the short term, there can be associated side effects, with some of these being ineffectiveness, non-tolerance, and dependency. Another limitation is their inability to induce REM, which is the most restorative stage of sleep. Therefore, it is important to develop aids that have little to no side effects while also inducing restorative sleep.

What is required of participants?

Your involvement in the study will be for 10 weeks. Most of the study requirements can be completed online at home; however, you will be required to attend our clinic (in Fortitude Valley, Brisbane) 3 times during the study.

During the study, you will be asked to:

  • Take the study product (in capsule form) 1 hour before bed each night for 8 weeks.
  • Wear an Oura Ring* sleep monitor continuously on 1 finger for 10 weeks.
  • Attend our clinic 3 times, on 2 of these occasions you will have a blood test.
  • Complete a series of short questionnaires at several point throughout the study.
  • Complete a sleep diary for a total of 15 days throughout the study.
  • Complete 5 salivary cortisol tests, which will be supplied to you to collect at home.

*The Oura Ring is designed to look like a traditional ring.

The information we collect during the study will enable the investigators to assess the product’s tolerability and efficacy in improving sleep quality.

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis. This means that your individual start date is flexible. The RDC Clinic is open 6 days a week (from 6.30am).

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.

Payment

Upon completion of the study requirements, you will be eligible for a $200 reimbursement for your time and travel expenses. The payment will be made via direct deposit to your nominated bank account once all study requirements have been met.

Pro rata payments are also available in the case of early withdrawal.

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.

Study Location

Our clinic is centrally located on Level 3, 252 St Pauls Terrace, Spring Hill. 

We offer free undercover parking directly next door under the Kennigo Hotel, 22 Kennigo Street, Spring Hill.

Getting to Us

  • Private Transport: free undercover parking available at Kennigo Hotel Car Park as well as metered street parking (availability for street parking is day/time dependent). Please enter 22 Kennigo Street, Spring Hill into your GPS.
  • Train: Fortitude Valley Train Station (350m away)
  • Bus: multiple bus stops within close proximity
Check if you can take part… study participant requirements.
  • Adults 18-65 years of age
  • Generally healthy with no uncontrolled or serious illnesses
  • BMI 18.5-33kg/m2 (you can check this on the BMI calculator on this page)
  • Experience mild to moderate sleep impairment
  • Able to provide informed consent
  • Able to commit to completing the study requirements

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 suitability.

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.

Check your BMI…

(eg 1.65)
Ethics approval & privacy… you’ll be in safe, professional hands.

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: (insert number). 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.