NEW STUDY ANNOUNCEMENT

Gut Microbiome Study

DO YOU WANT TO IMPROVE YOUR GUT HEALTH?

If so, you could help research new products in a

medical study to investigate their effectiveness on improving gut microbiome.

Check your eligibility here

If you have a BMI of 30-40(kg/m2) and interested in improving your gut microbiome, you could participate in this research.

We are looking for generally healthy adults aged 18-65 years old with a BMI of 30-40(kg/m2) who are interested in finding out more about their gut microbiome through a series of health assessments.

The study is examining the effectiveness of two non-pharmaceutical products oleoylethanolamide (OEA) and palmitoylethanolamide (PEA), for improving the gut microbiome.

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

So that we can scientifically measure the effectiveness of the products, you would be required to take the allocated study product twice-daily (in capsule form) for 12 weeks, and attend assessments at 3 timepoints (beginning, middle, and end). To make the timing of participation as convenient as possible for you, we are recruiting on a rolling basis, which means that your start date is flexible.

If you’d like to apply to take part in this study, we’d love to hear from you. More information is below, the eligibility & registration form is on this page.

What products are being researched?

This study is individually assessing both palmitoylethanolamide (PEA) and oleoylethanolamide (OEA) compared to a placebo. The investigational products, PEA and OEA have previously been researched for inducing satiety, improving gut health, improving metabolism and reducing pain & inflammation.

PEA is a TGA approved ingredient for use in listed medicines in Australia and is already on the market in Australia for other indications such as reducing inflammation and pain. In the body, PEA is synthesized from Palmitic acid (C16:0), the most common fatty acid in animals.

OEA is a metabolite of oleic acid. OEA has been used safely in clinical trials and is recognized as a safe (GRAS) compound in both humans and animals by the US Food and Drug Administration (FDA). OEA is primarily known for its anti-inflammatory properties and modulation of energy balance and appetite, particularly for its ability to induce satiety and help reduce food intake. More recently OEA has been shown to help protect gut integrity and modulate intestinal permeability.

Both PEA and OEA have a good tolerability and safety profiles, showing no serious adverse effects or symptoms in human and animal studies.

As this study is placebo controlled, you may or may not be allocated the active product.  Approximately 33% of the study group will be taking a placebo (an inactive substance). 

Why is this study being conducted?

The aim of this study is to assess the effectiveness of palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) compared to a placebo for improving gut microbiome in adults. 

Microbiota (bacteria) resides within the mucus lining of the gut and the beneficial microbiome abundance has been shown to be reduced in individuals with irritable bowel disease (IBD), as well as other chronic diseases like obesity and type II diabetes. Although not much is known about how the microbiome is involved in chronic disease, its ability to regulate the thickness of intestinal mucus appears to be the key. Microbiome residing within the mucus layer enables the mucus layer to regenerate by creating a constant turnover of the mucins. This constant consumption of old and production of new mucins creates a stable, healthy mucus barrier that helps protect the body from toxins. It is these toxins that can cross into the liver. 

What is required of participants?

Starting the Study: Following enrolment at the RDC Clinic, you will be allocated your study product to take for the duration of the study. However, before you start taking your trial product, you will be required to undergo 4 baseline assessments as follows:

  1. A blood test (approx 20mL) conducted during your initial enrolment visit at the RDC Clinic
  2. A diet recall and Quality of Life questionnaire completed during your initial enrolment visit at the RDC Clinic
  3. A liver scan at an external imaging centre (eg QScan)
  4. Fecal sample for microbiome testing which is collected by you at home with a supplied kit which you then post back in a reply paid envelope)

Once you have completed all baseline measures, you can start to take the supplied trial product daily as directed.

During the Study: You will take the trial product daily as directed for 12 weeks. You will be required to undertake identical testing to baseline at week 6 (mid-point) and week 12 (end-point), with the exception of the liver scan, which will not be undertaken at week 6.

The information we collect during the study will enable the investigators to assess the effectiveness of the products on improving parameters of gut health and associated quality of life.

If you’re an otherwise healthy adult with a BMI of 30-40kg/m2, and would like to participate, we’d love to hear from you. Please register your interest by answering the quick questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.  

What are the benefits to participants?

This study involves a number of health assessments which you may find of interest to you.

The Gut Microbiome testing in the study will provide a profile of your unique gut microbiome and provide information regarding the balance of your good and bad gut bacteria.

The liver scan will measure any scarring or tissue damage in your liver to better understand the condition of your liver.

Results of the liver scans and microbiome testing will be available approximately one month after you complete the Week 12 study requirements. In addition, this study is offering a reimbursement payment of $100 for completing participants.

Research is designed to benefit society by gaining new knowledge and improving the understanding of effective treatments for improved health and wellbeing. However, there may be no direct benefit to you from taking the study product.

Check if you can apply…

The study will involve approximately 120 otherwise healthy adults aged 18-65 years with a BMI of 30-40kg/m2. 

Are you…

  • Aged between 18-65
  • A BMI of 30-40kg/m2 (Please use the BMI calculator on this page)
  • A non-smoker?
  • Agree not to take other supplements (e.g. pre- and probiotics) or medications (e.g. antibiotics) that alter the gut microbiome or gut health for the duration of the study

And…

  • Have not experienced any acute sickness in the past 2 months
  • Are using a highly effective form of contraception if you are a female of child-bearing potential
  • Not suffering from or getting treated for any unstable or serious illness (eg kidney, liver, GIT, heart condition, diabetes, lung condition, malignancy) or any chronic disease in the last 6 months?
  • Are not using any long-term medication (e.g. NSAIDs, steroids, antibiotics) that would effect the immune and/or inflammatory response

In order to satisfy the full inclusion criteria, potential participants must undergo an initial telephone interview conducted by our trial investigators before enrollling in the study

Check your BMI…

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: 2020-07-675. The study is also registered on the Australian and New Zealand Clinical Trial Registry under Registration Number:  ACTRN12621000017820.

 

Trained Trial Co-ordinators will supervise your progress throughout the study. Any of your personal information collected during the study will be kept in the strictest confidence and no identifying information is ever published.

About the location of the study...you'll attend clinic appointments

Our clinic is located in Doggett Street, Newstead, Brisbane. 

We are walking distance from the Commercial Road Ferry Terminal & local buses, and a quick 10-minute walk from Bowen Hills train station. We also have onsite visitor parking available.