Gut-brain health effects of PREbiotics in older adults with suspected COgnitive DEcline: the PRECODE study

Recruiting

Conditions: personal experience of decreased cognitive ability with age
Subjective Cognitive Decline
10057167

Registration Number: NL-OMON56688

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 164

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. 99):
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
2 Defined 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are baseline (before week 1) and follow-up (after<br /><br>week 26) measures of<br /><br>(1) BOLD signal activity and task accuracy during n-back task fMRI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters include<br /><br>(1) Neuropsychological test battery (NTB)<br /><br>(2) Brain health parameters (in plasma): Tryptophan metabolites (indoles);<br /><br>Aβ1-42/Aβ1-40 ratio; cortisol levels; brain-derived neurotrophic factor (BDNF);<br /><br>T1/T2 weighted anatomical scans of brain regions of interest- hippocampus,<br /><br>temporal- and prefrontal cortices.<br /><br>(3) Gastrointestinal health parameters (plasma and faeces): intestinal barrier<br /><br>function, faecal microbiota composition (qualitative and quantitative),<br /><br>intestinal inflammation, intestinal transit time (ITT), short- (SCFA) and<br /><br>branched chain fatty acid (BCFA) concentrations, faecal water content & pH;<br /><br>gastrointestinal symptoms questionnaire and Bristol Stool Scale (BSS).<br /><br>(4) Immune and metabolic markers: inflammatory marker panel, fasting glucose<br /><br>and insulin, HbA1c, lipogram (LDL, HDL, total cholesterol, triglycerides).</p><br>