Effects of prebiotics on gut and brain health in older adults with cognitive decline
Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline: The PRECODE Study
This study is testing whether three types of dietary fibers can improve gut and brain health in older adults who are noticing memory problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 60 Years to 79 Years |
| Sex | All |
| Sponsor | Wageningen University Academic / other |
| Locations | 1 site (Wageningen) |
| Trial ID | NCT06433037 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of three different dietary fibers—chicory inulin, resistant dextrin, and seaweed polysaccharide—on gut and brain health in older adults aged 60 to 79 who experience subjective cognitive decline. Participants will receive either the dietary fibers or a placebo over a 26-week period. The study aims to explore the connection between gut health and cognitive function, particularly in relation to the gut-brain axis, which may play a role in preventing further cognitive decline. The findings could provide insights into dietary interventions for improving mental health in aging populations.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60-79 who report cognitive decline and have at least two risk factors for cognitive impairment.
Not a fit: Patients who are currently participating in other intervention trials or are technologically illiterate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve cognitive health and potentially delay the onset of dementia in older adults.
How similar studies have performed: While the gut-brain axis is a growing area of research, this specific approach using dietary fibers in older adults with subjective cognitive decline is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wageningen
- Wageningen University — Wageningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Yannick Vermeiren, PhD
- Email: yannick.vermeiren@wur.nl
- Phone: +31618520620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.