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

Cognitive Function Clinical Trial

Official title: Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in Older Adults - a Randomized Controlled Study

Status Not yet recruiting

Clinical Trial 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 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cognitive Function

• NCT number: NCT06353984
• Study type: Interventional
• Source: Örebro University, Sweden
• Contact: Cecilia Bergh, PhD
• Phone: +46 730682892
• Email: cecilia.bergh@oru.se
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Completion date: December 2025