subjective experience of decreased cognitive ability with age (=Subjective Cognitive Decline (SCD))
Conditions
Interventions
 
To investigate the effects of the 26 weeks of supplementation of the dietary fibres on the primary and secondary outcomes, four study arms - three interventions and one placebo- are applied, with diff
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion 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 self-reported risk factors for cognitive decline based on the weighted LIBRA criteria: at least 2 modifiable risk factors need to be present: (i) Diabetes mellitus type II 1 (has your doctor ever told you that you have diabetes yes/no) (ii) High cholesterol 1 (has your doctor ever told you your cholesterol is too high yes/no) (iii) Hypertension 1 (has your doctor ever told you that you have high blood pressure yes/no) (iv) High BMI 1,2 (v) Heart disease 1 (has your doctor ever told you that you have a heart or blood vessel condition) (vi) Unhealthy diet 1 (lower regular adherence to Mediterranean diet components such as fish, vegetables, olive oil, pasta and red wine)1Criteria defined by the short version questions from LIBRA Administration 2Defined as >=25 kg/m2 for 60-69 years old, and >=28 kg/m2 for >=70 years old, based on self-reported height and weight.
Exclusion criteria
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, psychosis, anxiety, posttraumatic stress disorder); - 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. Chron*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. Allergy 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 14. Any other relevant medical or surgical history that is not mentioned in above criteria, which could influence the study outcome measurements, as determined by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are baseline (before week 1) and follow-up (after week 26) measures of (1) BOLD signal activity and task accuracy during n-back task fMRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters include (1) Neuropsychological test battery (NTB). (2) Brain health parameters (in plasma): Tryptophan metabolites (indoles); Aß1-42/Aß1-40 ratio; cortisol levels; brain-derived neurotrophic factor (BDNF); T1/T2 weighted anatomical scans of brain regions of interest-hippocampus, temporal- and prefrontal cortices. (3) Gastrointestinal health parameters (plasma and faeces): intestinal barrier function, faecal microbiota composition (qualitative and quantitative), intestinal inflammation, intestinal transit time (ITT), short- (SCFA) and branched chain fatty acid (BCFA) concentrations, faecal water content & pH; gastrointestinal symptoms questionnaire and Bristol Stool Scale (BSS). (4) Immune and metabolic markers: inflammatory marker panel, fasting glucose and insulin, HbA1c, lipogram (LDL, HDL, total cholesterol, triglycerides). | — |
Countries
Netherlands
Contacts
Public ContactYPY Vermeiren
Wageningen Universiteit
Outcome results
None listed