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NCT05892627: PZAC
A Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
EARLY_PHASE1 trial testing PoZibio in Cognitive Decline in 40 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Aberystwyth University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 15 June 2023 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- PoZibio
- Placebo
Conditions studied
- Cognitive Decline — all drugs for Cognitive Decline →
Sponsor
Aberystwyth University
Who can join
50 and older, any sex, with Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic). The researchers will recruit a cohort of middle aged and older adults (\>50 years) who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks. Subjects will be asked to take both capsules in the morning with their breakfast. The placebo will be matched to the active product by taste and texture. Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task. The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial. The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial. Aim: A randomised, placebo controlled parallel human clinical trial of heat-treated Lactobacillus paracasei (post-biotics) in healthy middle aged and older subjects is proposed, to assess the potential for clinically relevant benefits in terms of cognitive function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05892627
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05892627 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aberystwyth University
- Last refreshed: 7 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05892627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing