Active, not recruiting
Not applicable
Effects of In-between Meal Products on Cognitive Function in the Elderly
Condition(s) studied
Cognitive Function
Investigational drug(s) / intervention(s)
Minimeal productReference product
Minimeal product: Intervention product consisting of bioprocessed oats and chickpeas
Reference product: Reference product mimicking available soups and fruit drinks
Study 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.
Eligibility
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 ingredients included in either investigational or reference products
* Regular smoking, use of snuff, nicotine, or e-cigarette use
* Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
* Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
* After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis
* Cerebral bleeding or history of cerebral bleeding
* Claustrophobia
* In operated apparatus (e.g., pacemaker)
* Aneurysm clips or shunts in the head
* Grenade-splinter or metal-splinter in the body (e.g., eyes)
* Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlea implant)
* Comprehensive tooth-implants or prosthesis
* Operated in the head or in the heart
* Swallowed a video-capsule
* Left-handed
* Severe vision impairments
* Being highly physically active, competing as a master athlete and/or partaking in physical demanding training more than four times per week, extreme exercising
* Any other reason the investigator feels the subject is not suitable for participation in this aspect of the study
Primary outcome measure(s)
- Functional brain activity — 9 weeks
Functional brain activity will be measured by functional magnetic resonance imaging (fMRI)) during the n-back task
Trial sites (1)
| Facility | City | Region | Status |
| Örebro University |
Örebro |
Sweden |
|
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