Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 4, 2026
Date Accepted: Aug 31, 2026
Effects of a nutritionally balanced between-meal food product on brain function in older adults: A study protocol for a randomized controlled trial (the MiniMeal study)
ABSTRACT
Background:
Increasing evidence suggests that diet influences gut microbiota composition and systemic inflammation, which in turn may affect brain health, cognitive function, and mood regulation. Elevated levels of systemic inflammation have been associated with reduced resting-state functional connectivity within the default mode network, a pattern linked to poorer cognitive performance in older adults. Dietary interventions incorporating anti-inflammatory foods, such as oat bran and chickpeas, may help attenuate low-grade inflammation and promote healthier dietary behaviors in ageing populations.
Objective:
This study protocol describes a randomized, controlled trial designed to investigate the effect of healthy between-meal products on brain activity in older adults.
Methods:
The MiniMeal study is a 9-week, 3-arm randomized, controlled trial comprising a blinded, 2-arm intervention and a non-blinded, no-intervention comparison group. A total of 114 community-dwelling men and women aged ≥70 years (38 per group), will be randomized to one of three study arms. Participants in the intervention group will consume the MiniMeal products, while those in the reference/control group will receive reference/control products. In both intervention arms, products will be consumed twice daily, either replacing or supplementing habitual morning, afternoon, or evening between-meal occasions. All other dietary habits will remain unchanged. Participants in the no-intervention group will maintain their habitual diet throughout the study period. The primary outcome is functional brain activity, assessed using functional magnetic resonance imaging (FMRI) during the n-back task, comparing the intervention and reference groups. Secondary outcomes include comparisons with the no-intervention group and assessment of other neural measures, biomarkers in blood, body composition, physical function, and self-reported well-being.
Results:
Ethical approval was obtained from the Swedish Ethical Review Authority (Etikprövningsmyndigheten) on February 20, 2024. Participant recruitment was completed on December 18, 2025. Data collection has completed by February 27, 2026. A total of 114 participants were enrolled, of whom 106 completed all six study visits.
Conclusions:
This study will provide insights into whether nutritious between-meal products can influence brain function in older adults and will explore potential underlying biological mechanisms. In addition, these findings may inform strategies to support well-being and mental health in later life, thereby contributing to healthy aging. Clinical Trial: ClinicalTrials.gov NCT06353984 registered 9 February 2024, https://clinicaltrials.gov/study/NCT06353984
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.