Effects of In-between Meal Products on Cognitive Function in the Elderly

NCT ID: NCT06353984

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

Intervention group receives the study product

Group Type: EXPERIMENTAL

Minimeal product

Intervention Type: DIETARY_SUPPLEMENT

Intervention product consisting of bioprocessed oats and chickpeas

Reference group

Reference group receives a reference product

Group Type: ACTIVE_COMPARATOR

Reference product

Intervention Type: DIETARY_SUPPLEMENT

Reference product mimicking available soups and fruit drinks

Control group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minimeal product

Intervention product consisting of bioprocessed oats and chickpeas

Intervention Type: DIETARY_SUPPLEMENT

Reference product

Reference product mimicking available soups and fruit drinks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Örebro University

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Cecilia Bergh, PhD

Role: CONTACT

cecilia.bergh@oru.se

+46 730682892

Ashley Hutchinson, PhD

Role: CONTACT

ashley.hutchinson@oru.se

Facility Contacts

Ashley Hutchinson, PhD

Role: primary

Cecilia Bergh, PhD

Role: backup

Other Identifiers

Minimeal 1.0

Identifier Type: -

Identifier Source: org_study_id