NCT06353984

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

Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Minimeal product	Intervention product consisting of bioprocessed oats and chickpeas
DIETARY_SUPPLEMENT	Reference product	Reference product mimicking available soups and fruit drinks

Timeline

• Start date: 2024-08-26
• Primary completion: 2027-01-01
• Completion: 2027-01-31
• First posted: 2024-04-09
• Last updated: 2026-02-18

Locations

1 site across 1 country: Sweden