protocolSection identificationModule nctId: NCT06353984, orgStudyIdInfo id: Minimeal 1.0, briefTitle: Effects of In-between Meal Products on Cognitive Function in Older Adults, acronym: Minimeal, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Investigators and participants are partly blinded as the control group receives no placebo product, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Minimeal product, interventions name: Reference product, outcomesModule primaryOutcomes measure: Functional brain activity, secondaryOutcomes measure: Fasting blood glucose/insulin, secondaryOutcomes measure: Blood fats/lipid status, secondaryOutcomes measure: Interleukin-6, secondaryOutcomes measure: High-sensitivity C-reactive protein, secondaryOutcomes measure: Tumor necrosis factor, secondaryOutcomes measure: Interferon-gamma, secondaryOutcomes measure: Zonulin, secondaryOutcomes measure: Intestinal fatty-acid binding protein, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Magnetic resonance imaging (MRI), secondaryOutcomes measure: The Perceived Stress Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: SF 36, secondaryOutcomes measure: Western Ontario and McMaster Osteoarthritis Index, secondaryOutcomes measure: Clinical Outcomes in Routine Evaluation, secondaryOutcomes measure: Gastrointestinal Symptoms Rating Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: International Physical Activity Questionnaire for the Elderly short form, secondaryOutcomes measure: Historical Physical Activity Questionnaire, secondaryOutcomes measure: Food frequency questionnaire, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Balance, secondaryOutcomes measure: 30-sec repeated chair raise, secondaryOutcomes measure: Maximal leg strength, secondaryOutcomes measure: Maximal handgrip strength, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False