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

NCT06353984 | Active Not Recruiting

• 1 other identifier: Minimeal 1.0
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function

Keywords

cognitive function

Outcome Measures

Primary Outcomes (1)

• Functional brain activity

  Functional brain activity will be measured by functional magnetic resonance imaging (fMRI)) during the n-back task

  9 weeks

Secondary Outcomes (30)

• Fasting blood glucose/insulin

  9 weeks

• Blood fats/lipid status

  9 weeks

• Interleukin-6

  9 weeks

• High-sensitivity C-reactive protein

  9 weeks

• Tumor necrosis factor

  9 weeks

Study Arms (3)

Intervention group

EXPERIMENTAL

Intervention group receives the study product

Dietary Supplement: Minimeal product

Reference group

ACTIVE COMPARATOR

Reference group receives a reference product

Dietary Supplement: Reference product

Control group

NO INTERVENTION

No intervention

Interventions

Minimeal product DIETARY_SUPPLEMENT

Intervention product consisting of bioprocessed oats and chickpeas

Intervention group

Reference product DIETARY_SUPPLEMENT

Reference product mimicking available soups and fruit drinks

Reference group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and participants are partly blinded as the control group receives no placebo product
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 9, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

SE (1)