PRECOG Pilot Project (NCT06911957) | Clinical Trial Compass
CompletedNot Applicable
PRECOG Pilot Project
United Kingdom50 participantsStarted 2025-05-01
Plain-language summary
This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
Who can participate
Age range60 Years – 75 Years
SexALL
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Inclusion Criteria:
* Aging between 60-75 years old
* Having normal vision and hearing
* Having a normal body mass index (BMI\<30)
Exclusion Criteria:
* Having mild to moderate subjective cognitive complaints
* Smoking
* Having food allergies
* Following restrictive and/or unbalanced diets
* Changing dietary intake majorly in past month
* Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
* Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
* Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
* Currently consuming prebiotic or probiotic supplements
* Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
* Continuous use of weight-loss drug for \> 1 month before screening
* Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
* Having a high fibre intake defined as \> 20g of fibre/day
* Wheat and/or gluten intolerance and having coeliac disease
What they're measuring
1
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
Timeframe: From baseline (pre intervention) to week 12 (post intervention)
2
Gut microbiome diversity
Timeframe: From baseline (pre intervention) to week 12 (post intervention)
3
Gut microbiome composition
Timeframe: From baseline (pre intervention) to week 12 (post intervention)