Effects of In-between Meal Products on Cognitive Function in the Elderly (NCT06353984) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of In-between Meal Products on Cognitive Function in the Elderly
Sweden114 participantsStarted 2024-08-26
Plain-language summary
The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The study products have the potential to lower chronic low-grade inflammation in the elderly, improve nutrition and thereby contribute to healthy aging including cognitive function, and the study will also give additional insight regarding secondary and exploratory outcomes.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* Signed informed consent prior to any study-related procedure
* Age 70 years and above
* Normal weight to overweight at the screening defined as BMI range 18.5-31.9
* Willing to abstain from regular consumption of medication known to alter gastrointestinal function or inflammatory status after being included and during the study
* Willingness to pick up study products and eat the products according to the instructions each day
Exclusion Criteria:
* Diagnosis of type 1 and/or type 2 diabetes
* Immobile (defined as the inability to participate in all study-related procedures)
* History of complicated gastrointestinal surgery
* Diagnosed inflammatory bowel disease (IBD)
* Current diagnosis of psychiatric disease/s or syndromes
* Current diagnosis of neurodegenerative disease
* Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
* Use of probiotics, prebiotics, fermented foods, kombucha, and any other product known to modulate gut microbiota composition in the last 2 months prior to inclusion
* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week in the last 2 months prior to inclusion
* Use of statins
* Consumption of any NSAID within 7 days of study start
* Any condition which could interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) as decided by the principal investigators' discretion
* Vegetarian diet
* Allergy to ingre…