The impact of Pozibio and/or Cerbella supplement on the function of the gut, brain, and gut-brain axis, when compared with a placebo control in healthy middle-aged and older adults

Not Applicable

• Conditions: Healthy middle-aged and older subjects to assess the potential for improved physiological, gut and cognitive health; Not Applicable

• Registration Number: ISRCTN75484092
• Lead Sponsor: Aberystwyth University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-23
• Last Update Posted: 30 September 2024
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Subjects over 60 years of age2. Subjects able to provide written informed consent PRIOR to performing any study procedures3. Subjects who can commit to visits to one of the centres4. Subjects who are willing to complete a series of questionnaires including the: Pittsburgh Sleep Quality Index (PSQI), Mini Mental State Exam (MMSE), 36-Item Short Form Health Survey (SF-36), Warwick-Edinburgh Mental Wellbeing Scale (WEMWS), and the Gastrointestinal Symptom Rating Scale (GSRS)5. Subjects who are willing to provide capillary blood, stool, and urine samples, and commit to EEG appointments

Exclusion Criteria

Current participant exclusion criteria as of 24/09/2024:1. Subjects with a diagnosis of Alzheimer’s disease, Parkinson's or other dementia2. 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 dementia3. Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening4. Subjects who are pregnant or lactating7. Subjects with a medical condition or disease that is life-threatening8. Subjects who smoke cigarettes or use other products containing nicotine9. Subjects who have been taking antibiotics, and/or having diarrhea and vomiting in the past 30 days10. Any subjects to whom PI feels not to be eligible based on critical conditions11. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health12. Subjects who are vegetarian/veganPrevious participant exclusion criteria:1. Subjects with a diagnosis of Alzheimer’s disease or other dementia2. 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 dementia3. Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening4. Subjects who are pregnant or lactating7. Subjects with a medical condition or disease that is life-threatening8. Subjects who smoke cigarettes or use other products containing nicotine9. Subjects who have been taking antibiotics, and/or having diarrhea and vomiting in the past 30 days10. Any subjects to whom PI feels not to be eligible based on critical conditions11. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health12. Subjects who are vegetarian/vegan

Study & Design

• Study Type: Interventional
• Study Design: Not specified