Effects of In-between Meal Products on Cognitive Function in Older Adults

Cognitive Function Clinical Trial

— Minimeal  

Official title:

Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in Older Adults - a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353984
• Other study ID #: Minimeal 1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Örebro University, Sweden
• Contact: Cecilia Bergh, PhD
• Phone: +46 730682892
• Email: cecilia.bergh[@]oru.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to any study-related procedure

• Minimal age 70 years

• BMI range 18.5-31.9 at the screening visit

• Will to abstain from 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

• Diagnosed inflammatory bowel disease (IBD)

• Current diagnosis of psychiatric disease/s or syndromes

• Current diagnosis of neurodegenerative disease

• 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

• Immobile (defined as the inability to participate in all study-related procedures)

• Being highly physically active, competing as a master athlete and/or partaking in physical demanding training more than four times per week, extreme exercising

• 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

• History of complicated gastrointestinal surgery

• 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

• 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

• Vision problems outside of the range -5 to +3

• Any other reason the investigator feels the subject is not suitable for participation in this aspect of the study

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Minimeal product
Intervention product consisting of bioprocessed oats and chickpeas
• Reference product
Reference product mimicking available soups and fruit drinks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional brain activity	Functional brain activity will be measured by functional magnetic resonance imaging (fMRI)) during the n-back task	9 weeks
Secondary	Fasting blood glucose/insulin	Fasting blood glucose insulin will be taken and the HOMA index (Homeostatic Model Assessment for Insulin Resistance) expressed in mmol/L or mg/dL will be used to assess insulin resistance	9 weeks
Secondary	Blood fats/lipid status	Blood fats/lipid status unit of measurement concentration given mmol/L	9 weeks
Secondary	Interleukin-6	Concentration of interleukin-6 measured in in blood serum corrected for baseline, unit of measurement concentration given as pg/mL	9 weeks
Secondary	High-sensitivity C-reactive protein	High-sensitivity C-reactive protein (HsCRP) measured in blood corrected for baseline, unit of measurement concentration given as mg/L	9 weeks
Secondary	Tumor necrosis factor	Concentration of Tumor necrosis factor (TNF) in blood serum corrected for baseline, unit of measurement concentration given as pg/mL	9 weeks
Secondary	Interferon-gamma	Concentration of Interferon-gamma (IFN-Gamma) in blood serum corrected for baseline, unit of measurement concentration given as pg/mL	9 weeks
Secondary	Zonulin	Zonulin (haptoglobin 2 precursor) is a protein that increases the permeability of tight junctions between cells of the wall of the digestive tract, measured in faeces.	9 weeks
Secondary	Intestinal fatty-acid binding protein	Intestinal fatty-acid binding protein (I-FABP) measured in faeces	9 weeks
Secondary	Cognitive function	Cognitive function will be assessed by an off-line multi-domain cognitive test battery computer-based, word recognition task	9 weeks
Secondary	Magnetic resonance imaging (MRI)	Resting state connectivity functional MRI (rsfMRI) and brain morphology from structural scans (brain and brain stem) are measured by MRI	9 weeks
Secondary	The Perceived Stress Scale	The Perceived Stress Scale (PSS) questionnaire is used to measure the perception of stress in life and has 10 questions with the following options to answer: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often	9 weeks
Secondary	Hospital Anxiety and Depression Scale	The validated Hospital Anxiety and Depression Scale (HADS) questionnaire will be used to assesses symptoms of depression and anxiety. The HADS has 7 questions related to depressions and 7 questions related to anxiety. A higher total score indicates more depression or anxiety with the following cut off scores: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)	9 weeks
Secondary	SF 36	The SF 36 (short form) questionnaire is used to assess general health Status. The SF-36 consists of 36 questions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life	9 weeks
Secondary	Western Ontario and McMaster Osteoarthritis Index	To evaluate hip and knee osteoarthritis Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire is used. The WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score	9 weeks
Secondary	Clinical Outcomes in Routine Evaluation	The translated and validated Swedish version of the Clinical Outcomes in Routine Evaluation (CORE-GP) is used to evaluate psychological wellbeing. The CORE-GP consists of 34 questions about how they have been feeling over the last week, using a 5-point scale (not at all, only occasionally, sometimes, often, most or all the time. The scale covers four dimensions: subjective well-being, problems/symptoms, life functioning, risk/harm	9 weeks
Secondary	Gastrointestinal Symptoms Rating Scale	To assess gastrointestinal symptoms the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire is used. The questionnaire consists of 15 questions combined into five symptom clusters: reflux, abdominal pain, indigestion, diarrhoea and constipation. Each questions is rated on a 7-point likert scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms	9 weeks
Secondary	Pittsburgh Sleep Quality Index	To assess sleep quality and sleep disturbances over a one-month time interval the Pittsburgh Sleep Quality Index (PSQI) questionnaire is used. Each questionnaire's 19 self reported items belong to one of seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction. The questionnaire consists of a combination of likert-type and open-ended questions. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.	9 weeks
Secondary	International Physical Activity Questionnaire for the Elderly short form	The International Physical Activity Questionnaire for the Elderly (IPAQ-E) short form consists of 4 questions regarding time spend sitting, walking, heavy physical activities or sport or very heavy activities or sport	9 weeks
Secondary	Historical Physical Activity Questionnaire	The Historical Physical Activity Questionnaire HAPAQ assesses physical activity behaviour between the age of 20 to 65 years and consists of questions regarding physical activity, sports and labour performed per year, month and average minutes per week	9 weeks
Secondary	Food frequency questionnaire	The Meal-Q Food frequency questionnaire is used to assess if participants have altered dietary patterns during the intervention. The questionnaire consists of 174 questions about foods, dishes and drinks (including alcoholic drinks) as well as pictures of different portion sizes for cooked dishes, questions about meal order, eating behaviour (with regard to restaurant visits, fast food, salad buffets, salt on food, consumption of diet products) and supplements.	9 weeks
Secondary	Physical activity	Habitual physical activity will be assessed by accelerometery activity monitor during a week during waking time. Counts per minute are registered and converted into daily average times spent in sedentary behaviour, light-intensity physical activity, and moderate-to-vigorous intensity physical activity.	Only at baseline (week 1)
Secondary	Muscle mass	Muscle mass is assessed with bioelectrical impedance (BIA)	9 weeks
Secondary	Fat mass	Fat mass is assessed with bioelectrical impedance (BIA)	9 weeks
Secondary	Body mass index	Body mass index (BMI) is calculated as weight (in kg)/ height^2 (in m^2)	9 weeks
Secondary	Waist circumference	Waist circumference is measured to the nearest 0.1 cm with a steel tape at the midpoint between iliac crest and lower costal marginBody mass index (BMI)	9 weeks
Secondary	Aerobic capacity	Aerobic capacity is assessed by a maximal walk test on a graded treadmill (Modified Bruce Protocol) where a further stage and time into the stage indicates a better aerobic fitness	9 weeks
Secondary	Balance	Balance by the single leg stance balance test with eyes open and eyes closed where longer time indicates a better balance	9 weeks
Secondary	30-sec repeated chair raise	Lower body muscle performance is assessed by the 30-sec repeated chair raise where more repetitions indicates a better performance	9 weeks
Secondary	Maximal leg strength	Maximal leg strength is assessed by the leg press exercise where a larger amount in kilograms lifted indicates a higher maximal leg strength	9 weeks
Secondary	Maximal handgrip strength	Maximal handgrip strength by the handgrip test where total amount of kilogram or kilogram per bodyweight indicates a higher total, or relative handgrip strength respectively	9 weeks