Effects of a drinkable meal on cognitive function in older adults
Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study
This study is testing whether a healthy drinkable meal made from oats and chickpeas can improve thinking and brain function in older adults aged 70 and up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT06353984 on ClinicalTrials.gov |
What this trial studies
This nine-week intervention involves a randomized controlled trial to assess how a healthy drinkable meal, made from processed oats and chickpeas, impacts cognitive function and brain activity in healthy adults aged 70 and older. Participants will be divided into three groups: two receiving the intervention and one serving as a non-blinded control. The study will also explore secondary outcomes related to inflammation, immune function, gut health, body composition, physical function, and overall well-being. Participants will attend the study center multiple times for assessments and sample collection throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 70 years and older with a normal to overweight BMI.
Not a fit: Patients with diabetes, immobility, or diagnosed neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance cognitive function and overall health in the elderly, contributing to healthier aging.
How similar studies have performed: While similar studies have explored dietary interventions for cognitive health, this specific approach using a drinkable meal is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Örebro
- Örebro University — Örebro, Sweden (Recruiting)
Study contacts
- Study coordinator: Cecilia Bergh, PhD
- Email: cecilia.bergh@oru.se
- Phone: +46 730682892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.