Effects of a supplement on cognitive function and brain activity in middle age and older healthy adults

Not Applicable

• Conditions: Clinically relevant benefits in terms of cognitive function; Not Applicable

• Registration Number: ISRCTN10175490
• Lead Sponsor: Welsh Government

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-15
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subjects over 50 years of age
2. Subjects with Mini-Mental State Exam (MMSE) of 25-30 inclusive (global cognitive function)
3. Subjects who are able to undergo EEG and to commit to visits to WARU/P5.
4. Subjects who are able to provide venous blood samples.
5. Subjects able to provide written informed consent PRIOR to performing any study procedures.

Exclusion Criteria

1. Subjects with diagnosis of Alzheimer's disease or other dementia
2. Subjects taking medication for the treatment of dementia (such as acetylcholinesterase inhibitors (Aricept, Excelon), memantine (Namenda) or other medications with similar mechanisms of action) or medical foods (such as Cerefolin, Souvenaid, Axona) for the treatment of dementia.
3. Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening.
4. Subjects with Geriatric Depression Scale > 6
5. Subjects with a Mini Mental State Exam score below 25
6. Subjects who are pregnant or lactating
7. Subjects with medical condition or disease that is life threatening
8. Subjects who smoke cigarettes or use other products containing nicotine.
9. Subjects diagnosed with diabetes.
10. Subjects taking warfarin.
11. Subjects who identify as being vegetarian or vegan
12. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health
13. Subjects who have immediate family members with diagnosed mental health condition or suspected mental health concerns

Study & Design

• Study Type: Interventional
• Study Design: Not specified