Your involvement in this study will be required for 12 weeks, 8 of which you will be required to take the Study Product.

To make the timings of study requirements as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible.

Most of the study requirements can be completed from home, but you will be required to attend two appointments.

Please see below for further information. You can find the registration of interest form at the bottom of this page.

For this study, we are assessing the effectiveness of two different doses of a milk protein compared to a placebo.  The product is provided as capsules.

 Participants will be asked to take 2 capsules daily for 8 weeks after a 4 week run in period where no product is taken.

 As this study is placebo-controlled, you will be randomly allocated to either one of the two active products or the placebo product on a chance basis. This means you will have a 2 in 3 chance of being allocated active study product, and a 1 in 3 chance of being allocated the placebo. During the study period, neither you nor the study investigators will know the product you have been allocated. However, if it is necessary for your health, we are able to discover which product you have been allocated.

 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.

The gastrointestinal tract is an important and complex organ system performing a range of functions essential to life such as digestion, absorption and excretion.  In some cases this complex system is affected by conditions or intolerances which cause gastrointestinal disturbances.  These disturbances are quite common, with nearly 45% of the population experiencing 1 or more upper gastrointestinal disturbance every 3 months.

The current study aims to assess the effectiveness of a milk protein product derived, Maolactin^TM, on gastrointestinal health.

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.

Most of the study requirements can be complete from home, but you will be required to attend either the RDC Clinic or ACL blood collection centre twice during the study. Please find a summary of the requirements below…

 Brisbane Participants

• You will be required to attend our clinic 2 times during the study. Each visit will take approximately 45 minutes and includes a fasted blood sample (5 minutes). You will be asked to fast from 10pm the night before your clinic visit (only water permitted), and may eat/drink immediately following your blood sample.

Sydney Participants

• You will be required to attend either the ACL Norwest or Darlinghurst collection centre 2 times during the study. Each visit will take approximately 20 minutes and includes a fasted blood sample (5 minutes). You will be asked to fast from 10pm the night before your clinic visit (only water permitted), and may eat/drink immediately following your blood sample.

From your Home

• 24 Hour Dietary Recalls – we will ask you to record all the food and drink that you consumed over a previous 24 hour period. You will be asked to complete a total of 12 diet recalls during the study. Each diet recall can take between 15-20 minutes to complete.
• Faecal samples – these are obtained by taking a small swab of faeces from the toilet paper after you have wiped. You will be provided with special collection kits and instructions, and will be asked to collect faecal samples at 2 timepoints during the study. Sample collection should take approximately 5 minutes to complete.
• Intestinal Permeability (Leaky Gut) Test – this test involves drinking a special sugar solution first thing in the morning, then collecting all of your urine for a period of 6 hours in a supplied container. Don’t worry, we will provide you with everything you need for this. You will be asked to complete this test at 2 timepoints during the study. Sample collection should only take a couple of minutes each time you go to the toilet within the 6 hour period. Please allow another 15-20 minutes to familiarise yourself with the instructions and complete the requirements.
• Online questionnaires – The questionnaires for this study are for collecting information about your general health and gut health. You will be asked to complete questionnaires at 5 timepoints during the study which will take approximately 15-20 minutes at each timepoint.

The information we collect during the study will enable the investigators to assess the product’s effectiveness on upper gastrointestinal disturbances.

After successfully completing the study requirements, you will be eligible for a reimbursement of $300 for your time. 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 cases of early withdrawal.

If you would like to participate, 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.

 Brisbane

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

 We have free undercover parking for participants directly next door under the Kennigo Hotel, 22 Kennigo Street, Fortitude Valley.

 Getting to Us

• Private Transport: free undercover parking available at Kennigo Hotel Car Park
• Train: Fortitude Valley Train Station (350m away)
• Bus: multiple bus stops within close proximity

Sydney

Participants will attend either of the below Australian Clinical Laboratories (ACL) clinics:

• Norwest Private Hospital – Suite G19, 11 Norbrik Drive Bella Vista
• Darlinghurst – Level 3, 393 Bourke Street Darlinghurst

• Adults 18 years and over
• Generally healthy with no uncontrolled serious illnesses
• Have a BMI of up to 35kg/m² (Please use the BMI calculator on this page)
• Experiencing moderate GI disturbances of the upper GI tract i.e. 1 or multiple symptoms (reflux, heartburn, regurgitation, nausea, bloating, abdominal pain) at least once a week for at least 3 months.
• 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…

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number:  2023-06-749. The study is also registered on the clinicaltrials.gov under Registration Number: NCT06104917.

Trained Trial Co-ordinators 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.