Aging
Conditions
Brief summary
Aging is associated with changes in a wide variety of brain networks, including the default mode, saliency attention, and visual networks. Furthermore, current research suggests that a relationship exists between functional connectivity at rest and cognition. Lactocaseibacillus rhamnosus is an ideal strain for the intervention, as it has been show to affect the gut-brain axis, brain function, and behavior. Therefore, the investigators plan to assess resting state functional magnetic resonance imaging (fMRI) to compare changes in brain connectivity between the groups receiving the encapsulate and non-encapsulated Lactocaseibacillus rhamnosus supplements.
Interventions
DIETARY_SUPPLEMENTMaltodextrin
Placebo product
DIETARY_SUPPLEMENTEncapsulated Lactocaseibacillus rhamnosus
Probiotic product
DIETARY_SUPPLEMENTNon-encapsulated Lactocaseibacillus rhamnosus
Probiotic product
Sponsors
Robert Brummer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent prior to any study-related procedure 2. Age 60-80 years-old 3. Normal weight at the screening defined as BMI range 18.5-31.9 4. Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) 5. Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
Exclusion criteria
1. Diagnosis of type 1 and/or type 2 diabetes 2. Current (or within the last 4 weeks prior to study start) use of probiotic supplementation 3. Immobile (defined as the inability to participate in all study-related procedures) 4. History of complicated gastrointestinal surgery 5. Diagnosed inflammatory bowel disease (IBD) 6. Current diagnosis of psychiatric disease/s or syndromes 7. Current diagnosis of neurodegenerative disease 8. Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion 9. Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months 10. Consumption of any NSAID within 7 days of study start 11. Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, irritable bowel syndrome (IBS), IBD) or in any other way with the outcome of the study, as decided by the principle investigator's discretion 12. Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use 13. Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion 14. 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.) 15. After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis 16. Cerebral bleeding or history of cerebral bleeding 17. Claustrophobia 18. In operated apparatus (e.g., pacemaker), as it interferes with MR imaging 19. Aneurysm clips in the head 20. Shunts in the head 21. Grenade-splinter or metal-splinter in the body (e.g., eyes) 22. Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant) 23. Comprehensive tooth-implants or prosthesis 24. Operated in the head 25. Operated in the heart 26. Swallowed a video-capsule, which may still be in the GI tract 27. Left-handed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | 6 weeks | corrected for baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function assessment using digit symbol substitution test (TMT) | 6 weeks | corrected for baseline, scale 0-93 points, higher scores indicate better cognition |
| Cognitive function assessment using letter comparison test | 6 weeks | corrected for baseline, scale 0-42 points, higher scores indicate better cognition |
| Cognitive function assessment using Rey-Auditory Verbal Learning Test | 6 weeks | corrected for baseline, scale 0-120 points, higher scores indicate better cognition |
| Cognitive function assessment using N-back task | 6 weeks | corrected for baseline, higher scores indicate better cognition |
| Cognitive function assessment using Face-Name Paired Associate Task (FNPA) | 6 weeks | corrected for baseline, higher scores indicate better cognition |
| Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha) | 6 weeks | corrected for baseline, unit of measurement concentration given as mg/ml |
| Levels of metabolic blood markers (blood fats) | 6 weeks | corrected for baseline, unit of measurement concentration given as mg/ml |
| Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin) | 6 weeks | corrected for baseline, unit of measurement concentration given as mg/ml |
| Characterisation of lymphocyte subpopulations using flow cytometry | 6 weeks | corrected for baseline |
| Faecal samples for evaluation of gut microbiota composition via next-generation sequencing (NGS) | 6 weeks | corrected for baseline |
| Levels of inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain using MR spectroscopy (MRS) | 6 weeks | corrected for baseline |
| Cognitive function assessment using the trail making test (TMT) | 6 weeks | corrected for baseline, scale 0-400 seconds and number of errors, higher scores indicate worse cognition |
| Cognitive function assessment using letter digit substitution test | 6 weeks | corrected for baseline, scale 0-135 points, higher scores indicate better cognition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characterisation of probiotic bacteria in faecal samples using flow cytometry | 6 weeks | corrected for baseline |
| Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS) | 3 weeks | corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms |
| Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI) | 3 weeks | corrected for baseline, scale 0-21, higher score indicates worse sleep |
| Assessment of psychological health using Perceived Stress Scale (PSS) | 3 weeks | corrected for baseline, scale 0-40, higher score indicates more perceived stress |
| Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS) | 3 weeks | corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms |
| Cognitive function assessment using the Montreal Cognitive Assessment (MoCA) | 6 weeks | corrected for baseline, scale 0-30 points, higher scores indicate better cognition |
| Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | 10-12 weeks | corrected for baseline |
| Brain stem functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | 6 weeks | corrected for baseline |
| Brain structure measured by magnetic resonance imaging (fMRI) | 6 weeks | corrected for baseline |
Countries
Sweden
Outcome results
None listed