Phase
Condition
Mild Cognitive Impairment
Memory Loss
Memory Problems
Treatment
Resistant dextrin
Seaweed polysaccharide
Placebo
Clinical Study ID
Ages 60-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent
Fluency in Dutch (speaking, reading, writing)
Age between 60-79 years (at screening)
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;
- Presence of at least 2 self-reported risk factors for cognitive decline (based onLIBRA criteria): (i) Diabetes mellitus type II (ii) High cholesterol (iii)Hypertension (iv) High BMI (v) Heart disease (vi) Unhealthy diet (lower regularadherence to Mediterranean diet components such as fish, vegetables, olive oil,pasta and red wine)
Exclusion
Exclusion Criteria:
Current participation in other intervention trials
Technologically illiterate (complete incompetence in working with computers, apps,online questionnaires, smartwatches etc.)
No internet access from home
Clinical diagnosis of ≥1 of the following:
Neurological pathology (e.g. MCI, dementia, multiple sclerosis, Parkinson'sdisease, epilepsy);
Current malignant disease(s), with or without treatment;
Current psychiatric disorder(s) (e.g. major depressive disorder, bipolardisorder, 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 orinflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
Current or recent (<6 weeks) use of prebiotic, probiotic, or dietary fibresupplement that may modulate the microbiota, or unwilling to stop the use ofsupplements during the study
Current or recent (<6 weeks) of algae/phytoplankton supplements such as spirulina orchlorella, or unwilling to stop the use of supplements during the study
Use of psychotropic medication (anti-depressants, anti-psychotics)
Use of antibiotics in the 3 months before starting the study or planned use duringthe study
Being an employee of the Human Nutrition and Health Division of WageningenUniversity.
Significant cognitive impairment assessed using the Modified Telephone Interview forCognitive Status battery (TICS-m score <23)
Request to have Apo-E genotype result disclosed
Allergies to fish or shellfish
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 heartvalve
Intra-orbital or intra-ocular metallic fragments
Claustrophobia
Study Design
Study Description
Connect with a study center
Wageningen University
Wageningen,
NetherlandsActive - Recruiting
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