STUDY ANNOUNCEMENT

Inflammation and Muscle/Joint Comfort Study

Are you experiencing muscle or joint pain?

We are seeking adults 45-65 years who are currently experiencing muscle or joint pain for a study assessing the effectiveness of an investigational product designed to reduce inflammation and muscle/joint pain.

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 approximately 8 weeks. During this time, you will be required to take the study product each day. We are recruiting on a rolling basis which means that your individual start date is flexible.

To complete this study, you will be required to attend the ACL Norwest or Darlinghurst pathology clinics in Sydney.

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 protein-based supplement called Maolactin in people with elevated inflammation and mild to moderate muscle or joint pain. Maolactin is a natural, milk-based protein supplement. The supplement contains a blend of functional proteins formulated to lower inflammation and enhance muscle recovery. This innovative product is aimed at assisting athletes of all skill levels, as well as the elderly, in improving mobility and enhancing exercise recovery.

The product will be supplied in capsule form, and participants will be asked to take 2 capsules daily 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 is 1 active group and 1 placebo group, so you will have a 50% 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?

As we age, we tend to have an increase in inflammation production both at rest and during physical activity that can affect our muscles and joints negatively. Due to the potential issues that can arise with both age and exercise, supplement options need to be available to help decrease skeletal muscle inflammation as well as everyday muscle and joint pains

Those who suffer from inflammation and/or muscle and joint pain turn to aids to assist and improve their daily activity. These can include prescription and over the counter medications or herbal supplements. Whilst some of these may be effective in the short term, there can be associated side effects, some being ineffective, poorly tolerated, and/or create dependency.  Therefore, it is important to develop aids that have little to no side effects while also addressing the cause of the problem.

What is required of participants?

Your involvement in the study will be for approximately 8 weeks. Most of the study requirements can be completed online at home; however, you will be required to attend either the ACL Norwest or Darlinghurst pathology clinic twice during the study.

During the study, you will be asked to:

  • Take the study product (in capsule form) for 8 weeks.
  • Attend a pathology clinic 2 times, to have a blood test.
  • Complete a series of short questionnaires at several points throughout the study.

The information we collect during the study will enable the investigators to assess the product’s tolerability and efficacy in improving inflammation and muscle and joint pain.

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.

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 $150 reimbursement for your travel expenses. The payment will be made via direct deposit to your nominated bank account once all study requirements have been met. You can also elect to be reimbursed with vouchers.

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

This study is a remote study, meaning most of the study is complete over the phone and online. In addition, you will be required to attend either the ACL Norwest or Darlinghurst pathology clinic.

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

(eg 1.65)

Check if you can register to take part…
  • Adults 45-65 years of age
  • Generally healthy with no uncontrolled or serious illnesses
  • BMI 25-35 kg/m2 (you can check this on the BMI calculator on this page)
  • Feel pain or discomfort in joints or muscles for at least 3 months
  • Inflammation (CRP) equal to or greater than 2.0 mg/L (we will test for this)
  • 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.

Ethics approval and privacy

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.