Atlantia Type II Diabetes Study

Name of Study

 

Atlantia Type II Diabetes Study

 

Purpose of Study

Atlantia Food Clinical Trials is carrying out a study that will test if the investigational product, a probiotic, can help improve markers of metabolic health (e.g. glucose, insulin and blood lipid levels) of type 2 diabetes adults by modulating the makeup of the gut microbiome.

 

 

Type of Study (observational/exploratory etc.)

Food Intervention Study

 

Are you recruiting participants for this trial?

 

Yes

 

Geographical location of study 

 

Cork

 

Who can take part?

Aged 18-75, diagnosed Type II Diabetic and residing in the Cork area.

 

What will the participants be asked to do?

 

In short, participants will attend 7 visits over a 12 week period at the study site in Cork. They will be required to wear a continuous glucose monitoring (CGM) sensor, which a research nurse will provide you with instructions on how to change at home. This will allow the participant monitor their blood glucose. We will also complete a health check with each participant. They will receive a supply of the investigational supplement or placebo.

You will then be required to complete a Mixed Meal Tolerance Test (MMTT) at each visit.

A MMTT is performed as follows:
– A cannula will be inserted into your arm.
– A blood sample will be collected before you take the product.
– You will consume the MMTT product.
– A blood sample will be collected 60 and 120 minutes after the you take your first sip.
– You will be asked to remain seated for the duration of test.

If you attend all 7 study visits described above, you will receive a financial compensation of €575 to cover your time and any expenses incurred.

 

 

Recruitment Start Date

 

08/08/2019

 

Recruitment Finish Date

 

Open Date

 

Study Duration

12 weeks

 

 

This study is funded by:

n/a

 

For further information contact:

 

Dr Niamh Aspell, PhD

 

Phone

 

087 371 1578

 

Email

 

[email protected]