Effect of Encapsulated vs Free Probiotic on Brain Function

Aging Clinical Trial

Official title:

Comparing the Efficacy of Micro-encapsulated Lactocaseibacillus Rhamnosus vs Free Probiotic in Powder to Affect Brain Connectivity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05801042
• Other study ID #: AnaBio
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Maltodextrin
Placebo product
• Encapsulated Lactocaseibacillus rhamnosus
Probiotic product
• Non-encapsulated Lactocaseibacillus rhamnosus
Probiotic product

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Robert Brummer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brain stem functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)	corrected for baseline	6 weeks
Other	Brain structure measured by magnetic resonance imaging (fMRI)	corrected for baseline	6 weeks
Other	Characterisation of probiotic bacteria in faecal samples using flow cytometry	corrected for baseline	6 weeks
Other	Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS)	corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms	3 weeks
Other	Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS)	corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms	6 weeks
Other	Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI)	corrected for baseline, scale 0-21, higher score indicates worse sleep	3 weeks
Other	Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI)	corrected for baseline, scale 0-21, higher score indicates worse sleep	6 weeks
Other	Assessment of psychological health using Perceived Stress Scale (PSS)	corrected for baseline, scale 0-40, higher score indicates more perceived stress	3 weeks
Other	Assessment of psychological health using Perceived Stress Scale (PSS)	corrected for baseline, scale 0-40, higher score indicates more perceived stress	6 weeks
Other	Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS)	corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms	3 weeks
Other	Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS)	corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms	6 weeks
Other	Cognitive function assessment using the Montreal Cognitive Assessment (MoCA)	corrected for baseline, scale 0-30 points, higher scores indicate better cognition	6 weeks
Other	Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)	corrected for baseline	10-12 weeks
Other	Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS)	corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms	10-12 weeks
Other	Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI)	corrected for baseline, scale 0-21, higher score indicates worse sleep	10-12 weeks
Other	Assessment of psychological health using Perceived Stress Scale (PSS)	corrected for baseline, scale 0-40, higher score indicates more perceived stress	10-12 weeks
Other	Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS)	corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms	10-12 weeks
Other	Brain structure measured by magnetic resonance imaging (fMRI)	corrected for baseline	10-12 weeks
Primary	Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)	corrected for baseline	6 weeks
Secondary	Levels of inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain using MR spectroscopy (MRS)	corrected for baseline	6 weeks
Secondary	Cognitive function assessment using the trail making test (TMT)	corrected for baseline, scale 0-400 seconds and number of errors, higher scores indicate worse cognition	6 weeks
Secondary	Cognitive function assessment using digit symbol substitution test (TMT)	corrected for baseline, scale 0-93 points, higher scores indicate better cognition	6 weeks
Secondary	Cognitive function assessment using letter digit substitution test	corrected for baseline, scale 0-135 points, higher scores indicate better cognition	6 weeks
Secondary	Cognitive function assessment using letter comparison test	corrected for baseline, scale 0-42 points, higher scores indicate better cognition	6 weeks
Secondary	Cognitive function assessment using Rey-Auditory Verbal Learning Test	corrected for baseline, scale 0-120 points, higher scores indicate better cognition	6 weeks
Secondary	Cognitive function assessment using N-back task	corrected for baseline, higher scores indicate better cognition	6 weeks
Secondary	Cognitive function assessment using Face-Name Paired Associate Task (FNPA)	corrected for baseline, higher scores indicate better cognition	6 weeks
Secondary	Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)	corrected for baseline, unit of measurement concentration given as mg/ml	6 weeks
Secondary	Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)	corrected for baseline, unit of measurement concentration given as mg/ml	3 weeks
Secondary	Levels of metabolic blood markers (blood fats)	corrected for baseline, unit of measurement concentration given as mg/ml	6 weeks
Secondary	Levels of metabolic blood markers (blood fats)	corrected for baseline, unit of measurement concentration given as mg/ml	3 weeks
Secondary	Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin)	corrected for baseline, unit of measurement concentration given as mg/ml	6 weeks
Secondary	Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin)	corrected for baseline, unit of measurement concentration given as mg/ml	3 weeks
Secondary	Characterisation of lymphocyte subpopulations using flow cytometry	corrected for baseline	6 weeks
Secondary	Faecal samples for evaluation of gut microbiota composition via next-generation sequencing (NGS)	corrected for baseline	6 weeks