Clinical trial NCT06353984: Effects of In-between Meal Products on Cognitive Function in the Elderly
Official title: Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Function
Keywords: cognitive function
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 114
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention
Primary purpose: PREVENTION

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
* Use of probiotics, prebiotics, fermented foods, kombucha, and any other product known to modulate gut microbiota composition in the last 2 months prior to inclusion
* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week in the last 2 months prior to inclusion
* 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
* Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
* 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
* Claustrophobia
* In operated apparatus (e.g., pacemaker)
* Aneurysm clips or shunts in the head
* Grenade-splinter or metal-splinter in the body (e.g., eyes)
* Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlea implant)
* Comprehensive tooth-implants or prosthesis
* Operated in the head or in the heart
* Swallowed a video-capsule
* Left-handed
* Severe vision impairments
* Being highly physically active, competing as a master athlete and/or partaking in physical demanding training more than four times per week, extreme exercising
* Any other reason the investigator feels the subject is not suitable for participation in this aspect of the study

Primary outcomes:
measure: Functional brain activity
timeFrame: 9 weeks
Secondary outcomes:
measure: Fasting blood glucose/insulin
timeFrame: 9 weeks
measure: Blood fats/lipid status
timeFrame: 9 weeks
measure: Interleukin-6
timeFrame: 9 weeks
measure: High-sensitivity C-reactive protein
timeFrame: 9 weeks
measure: Tumor necrosis factor
timeFrame: 9 weeks
measure: Interferon-gamma
timeFrame: 9 weeks
measure: Zonulin
timeFrame: 9 weeks
measure: Intestinal fatty-acid binding protein
timeFrame: 9 weeks
measure: Cognitive function
timeFrame: 9 weeks
measure: Magnetic resonance imaging (MRI)
timeFrame: 9 weeks
measure: The Perceived Stress Scale
timeFrame: 9 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 9 weeks
measure: SF 36
timeFrame: 9 weeks
measure: Western Ontario and McMaster Osteoarthritis Index
timeFrame: 9 weeks
measure: Clinical Outcomes in Routine Evaluation
timeFrame: 9 weeks
measure: Gastrointestinal Symptoms Rating Scale
timeFrame: 9 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 9 weeks
measure: International Physical Activity Questionnaire for the Elderly short form
timeFrame: 9 weeks
measure: Historical Physical Activity Questionnaire
timeFrame: 9 weeks
measure: Food frequency questionnaire
timeFrame: 9 weeks
measure: Physical activity
timeFrame: Only at baseline (week 1)
measure: Muscle mass
timeFrame: 9 weeks
measure: Fat mass
timeFrame: 9 weeks
measure: Body mass index
timeFrame: 9 weeks
measure: Waist circumference
timeFrame: 9 weeks
measure: Aerobic capacity
timeFrame: 9 weeks
measure: Balance
timeFrame: 9 weeks
measure: 30-sec repeated chair raise
timeFrame: 9 weeks
measure: Maximal leg strength
timeFrame: 9 weeks
measure: Maximal handgrip strength
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References: