Effects of In-between Meal Products on Cognitive Function in Older Adults (Minimeal)

Örebro University, Sweden

Status: Begins enrollment this month

Conditions: Cognitive Function

Treatments: Dietary Supplement: Minimeal product; Dietary Supplement: Reference product

Study type: Interventional

Funder types: Other

Identifiers

NCT06353984

Minimeal 1.0

Details and patient eligibility

About

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 present study has as the potential to prevent or slow down the onset of cognitive decline as it targets healthy older adults and gives additional insight regarding secondary and exploratory outcomes.

Full description

The current study is a nine week three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded comparative arm without any intervention. This study will investigate the effects of a healthy in between meal consisting of processed oats and chickpeas on cognitive function and functional brain activity in healthy older men and women 70 years and older (primary endpoints) and explore the effect of the intervention product on blood markers, body composition, physical activity, physical function, and self-reported well-being in the earlier mentioned population (secondary endpoint). Furthermore, the study will give insight in the preventative value of the intervention product on earlier mentioned age-related conditions as well as adherence to the study product and gives guidance towards further research regarding the effect of food product on age related conditions. Participants will visit the study centre at seven occasions, one time before (pre visit) and six times during the study period to perform one or more tests and/or examinations. The pre visit takes place before the baseline, visit 1 and 2 are at baseline, and visit 3 and 4 are the mid-study-visits in week 3 and 6 of the interventional period. Visit 5 and 6 take place at the last interventional week, ie week 9. Data and sample collection takes place as following:

visit 0: Eligibility screening and informed consent Week 1: visit 1 baseline: Body composition, blood samples, fecal samples, questionnaires and physical activity and function, cognitive function Week 1: visit 2 baseline fMRI: Structural MRI, RS-(MRI), N-back task fMRI, word recognition task Week 3: visit 3 intermediate visit I: Body composition, blood samples, questionnaires, compliance Week 6: visit 4 Intermediate visit I: Body composition, blood samples, questionnaires, compliance Week 9: visit 5 study end: same procedure as visit 1 Week 9. Visit 6 study end: same procedure as visit 2

Enrollment: 114 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed informed consent prior to any study-related procedure
• Minimal age 70 years
• BMI range 18.5-31.9 at the screening visit
• Will to abstain from 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
• Diagnosed inflammatory bowel disease (IBD)
• Current diagnosis of psychiatric disease/s or syndromes
• Current diagnosis of neurodegenerative disease
• 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
• Immobile (defined as the inability to participate in all study-related procedures)
• Being highly physically active, competing as a master athlete and/or partaking in physical demanding training more than four times per week, extreme exercising
• 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
• History of complicated gastrointestinal surgery
• 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
• 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
• Vision problems outside of the range -5 to +3
• Any other reason the investigator feels the subject is not suitable for participation in this aspect of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

114 participants in 3 patient groups

Intervention group

Experimental group

Description:

Intervention group receives the study product

Treatment:

Dietary Supplement: Minimeal product

Reference group

Active Comparator group

Description:

Reference group receives a reference product

Treatment:

Dietary Supplement: Reference product

Control group

No Intervention group

Description:

No intervention