Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline

Launched by WAGENINGEN UNIVERSITY · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether certain types of dietary fibers can help improve gut and brain health in older adults who are experiencing early signs of cognitive decline, known as Subjective Cognitive Decline (SCD). Participants, aged 60 to 79, will take one of three different dietary fibers twice a day for 26 weeks. Researchers want to see if these fibers can enhance memory, overall brain function, gut health, mood, and even support the immune system and blood sugar levels.

To be eligible, participants need to notice some memory problems and have at least two risk factors for cognitive decline, such as high blood pressure or an unhealthy diet. Throughout the study, they will undergo tests to measure brain function, complete questionnaires about their health and mood, and wear smartwatches to track their activity. Participants will also have two brain scans and additional visits to provide blood and urine samples. This trial aims to better understand the connection between gut health and brain health, which could lead to new ways to support cognitive function in older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. Fluency in Dutch (speaking, reading, writing)
• • 3. Age between 60-79 years (at screening)
• 4. Subjective cognitive decline plus (SCD+), (criteria of Jessen et al.):
• • 4.1 Self-reported worsening of memory; 4.2 Indication of repetitive concerns (worries) associated with SCD; 4.3 With at least one of the following two features present: (i) onset of SCD within the last 5 years; (ii) age at onset ≥60 years of age;
• • 5. Presence of at least 2 self-reported risk factors for cognitive decline (based on LIBRA criteria): (i) Diabetes mellitus type II (ii) High cholesterol (iii) Hypertension (iv) High BMI (v) Heart disease (vi) Unhealthy diet (lower regular adherence to Mediterranean diet components such as fish, vegetables, olive oil, pasta and red wine)
• Exclusion Criteria:
• • 1. Current participation in other intervention trials
• • 2. Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, smartwatches etc.)
• • 3. No internet access from home
• 4. Clinical diagnosis of ≥1 of the following:
• • Neurological pathology (e.g. MCI, dementia, multiple sclerosis, Parkinson's disease, epilepsy);
• • Current malignant disease(s), with or without treatment;
• • Current psychiatric disorder(s) (e.g. major depressive disorder, bipolar disorder, schizophrenia, anxiety, psychosis, PTSD);
• • Symptomatic/decompensated cardiovascular disease (e.g. stroke, angina pectoris, heart failure, recent myocardial infarction);
• • Severe visual impairment or blindness
• • Hearing or communicative impairment.
• • Gastrointestinal tract disorder such as irritable bowel syndrome or inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
• • 5. Current or recent (\<6 weeks) use of prebiotic, probiotic, or dietary fibre supplement that may modulate the microbiota, or unwilling to stop the use of supplements during the study
• • 6. Current or recent (\<6 weeks) of algae/phytoplankton supplements such as spirulina or chlorella, or unwilling to stop the use of supplements during the study
• • 7. Use of psychotropic medication (anti-depressants, anti-psychotics)
• • 8. Use of antibiotics in the 3 months before starting the study or planned use during the study
• • 9. Being an employee of the Human Nutrition and Health Division of Wageningen University.
• • 10. Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICS-m score \<23)
• • 11. Request to have Apo-E genotype result disclosed
• • 12. Allergies to fish or shellfish
• 13. Having a contra-indication to MRI scanning including:
• * Ferromagnetic implants:
• • Active implantable medical devices such as: insulin pump / medicine pump / neurostimulator; pacemaker / defibrillator;
• • Other passive implants such as: punctured port-a-cath; synthetic heart valve
• • Intra-orbital or intra-ocular metallic fragments
• • Claustrophobia