What is the study about?
The PRIME study stands for PRebiotic Intervention for Metabolic and MEntal Health. This study is being conducted by myota health and has been approved by the NHS Research Ethics Committee.
We're looking for people with symptoms of metabolic syndrome to take part in our 12-week study exploring the effects of prebiotic fibre on inflammation, the gut microbiome, and mental health.
We will only be recruiting participants until August 2023, so please ensure that you enquire soon to avoid missing out.
What is metabolic syndrome?
Metabolic syndrome is a cluster of symptoms that occur together, which increase your risk of heart disease, stroke, and type 2 diabetes. These symptoms include:
- BMI greater than 25kg/m2
- High blood pressure
- High blood sugar
- Excess body fat around the waist
- High LDL cholesterol or triglyceride levels (the "bad" cholesterol)
- Low levels of HDL cholesterol (the "good" cholesterol)
New scientific research suggests that prebiotic fibres can reduce cholesterol, blood pressure, and blood sugars, and improve mental health. These benefits are thought to influenced by our gut microbiome, and the anti-inflammatory effects of short-chain fatty acids (SCFAs) in the gut.
To be eligible for the study, you must meet at least 3 criteria for metabolic syndrome. As we are looking at the effect of myota on various health markers, you cannot be currently taking myota products. You can find these in the screening questionnaire when you sign up.
What do I receive for participating?
You will receive access to:
- 2 x personalised gut microbiome reports (RRP £438)
- 2 x inflammatory and cholesterol reports (RRP £70)
- 3 month’s worth of myota’s Immunity Booster blend to trial (RRP £120)
- A £25 gift voucher
- Contribute to cutting-edge research in the field of gut microbiome science and help us find novel approaches to reduce the risk of chronic disease
Complete the eligibility form and book a screening call with a member of our research team.
2. Receive Study Kit
Receive your study kit in the mail and read the instructions.
3. Baseline Tests
Complete a finger-prick test and a gut microbiome sample. Answer some online surveys.
4. Start the Intervention
You will be asked to take a daily prebiotic fibre supplement for 12 weeks. If you are randomised to the control group, you will continue with your normal diet and lifestyle.
5. Online Surveys
During the 12-week study, you will be asked to answer online surveys once a week (2-min survey).
6. Repeat Baseline Tests
At the end of the study, you will take the same tests that you did at baseline. If you were allocated to the control group, you will now receive 3 month's of myota to enjoy!
Recruiting now until August 2023
We will be recruiting participants on a first come first serve basis until August 2023. To ensure you don't miss out, please ensure you complete the screening questionnaire below.
If you don't see your question listed here, please reach out to us at firstname.lastname@example.org
How do I know if I'm eligible?
Click on the link on this page to check your eligibility for the study. If you're not sure, you can reach out directly to the research team at email@example.com
How do I sign up?
The first step is to complete the enquiries form. If you are eligible for the study, you will then need to book a screening call with a member of the research team who will enrol you into the study.
What does a randomised control trial mean?
A randomised controlled trial (RCT) is a study that measure the effectiveness of a new intervention or treatment. This study design has two different groups: the fibre intervention and the control (comparison) group. If you are randomised to the fibre intervention, you will be asked to consume our prebiotic fibre supplement daily for 12 weeks. If you are randomised into the control group, you will be asked to continue with your normal lifestyle and diet. At the end of the study, participants in the control group will receive 3 month's worth of free prebiotic fibre.
Who is conducting this study?
This study is led by the Head of Clinical Research at myota health. This study has received human ethical clearance through the NHS REC.
Where is this study located?
This study is a remote study, which means that you won’t need to attend a clinic or physical location during the study. We will send you everything you need by mail. The only study requirements that take place outside of the house may be to get your blood pressure and weight recorded at a local pharmacy (unless you can do this at home).
How long will the study run for?
We are recruiting participants until the end of August, so make sure to register your interest before it closes.
What happens to my data?
Any data that we collect from you will be kept confidential at all times. You will be allocated a study ID number to be used on all questionnaires. Your personal information will be kept securely on a password protected drive. This will only be accessible to the research team and will only be accessed when the team need to contact you for the next stage of the study or to send you details of the results. You may be contacted by a GP if your blood test results require further investigation.