Active, not recruiting
Not applicable
Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline
Condition(s) studied
Subjective Cognitive Decline
Investigational drug(s) / intervention(s)
Chicory inulinResistant dextrinSeaweed polysaccharidePlacebo
Chicory inulin: Chicory inulin (12g/day) divided over two dosages (6g per dose)
Resistant dextrin: Resistant dextrin (14g/day) divided over two dosages (7g per dose)
Seaweed polysaccharide: Seaweed polysaccharide (1g/day) divided over two dosages (0.5g per dose). Additionally contains 7g/day of placebo as a volumetric and isocaloric filler.
Placebo: Maltodextrin (7g/day) will be provided in two divided doses (3.5g per dose)
Study summary
As people around the world are living longer, the number of individuals with dementia, particularly Alzheimer's disease (AD), is expected to triple by 2050. There's growing evidence suggesting that our gut health might play a role in the prevention of dementia. The connection between our gut and brain, known as the gut-brain axis, is becoming an important area of study. Research in animals has shown that different types of dietary fibre can improve gut health, brain function, mood, blood sugar level and the immune system and may even prevent certain harmful brain changes seen in Alzheimer's disease. Subjective Cognitive Decline (SCD) is a condition where individuals notice a decline in their mental abilities, and it can be an early sign of Alzheimer's disease.
The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals, between the ages of 60 and 79 years, who notice problems in their mental abilities, and meet the criteria of SCD. Three different dietary fibres will be given, and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo.
The main questions it aims to answer are:
1. Does dietary fibre improve working memory?
2. Does dietary fibre improve other markers of brain function?
3. Does dietary fibre improve gut health?
4. Does dietary fibre improve the immune system and blood glucose levels?
5. Does dietary fibre improve mood?
Participants will:
* Consume dietary fibres twice a day, mixed in water, tea or coffee, for a period of 26 weeks
* Have two functional MRI scans, and three additional study visits, where blood, urine and feces will be collected
* Undergo a number of neuropsychological tests, aimed at evaluating brain function
* Fill out questionnaires on their general health, mood, dietary habits, gut health
* Wear smartwatches for one week, at the beginning and the end of the study
Eligibility
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
Primary outcome measure(s)
- Effect on working memory during n-back task fMRI — Measured at baseline and week 26
Effects on working memory will be assessed by blood-oxygen level dependant (BOLD) signal activity during 2-back task performed during fMRI scanning
- Effect on working memory performance during n-back task fMRI — Measured at baseline and week 26
Effects on working memory performance will be assessed by task accuracy during 2-back task performed during fMRI scanning
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Wageningen University |
Wageningen |
Netherlands |
|
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