risicofactoren voor cognitieve achteruitgang (cognitieve veroudering) en darmmicrobioom dysbiose brain health gut health
Conditions
Interventions
This study will have two intervention arms, namely a targeted gut intervention
with a colon-delivered multivitamin supplement (consisting of vitamins B2, B3,
B6, B9, C, and D3) and a placebo conditi
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age between 60-75 years (at pre-screening) - Fluency in Dutch (speaking, reading and writing) - Score >=2 points on the risk factors listed below: 1. BMI >=25 (1 point) 2. Physical inactivity (below the 2020 WHO guidelines, meaning: <150 min of moderate intensity aerobic physical activity, or <75 min of vigorous intensity aerobic physical activity per week, spread out over several days) (1 point) 3. Hypertension (1 point, 2 points if hypertension is untreated) 4. Hypercholesterolemia (1 point) 5. Diabetes type-II (1 point) 6. Cardiovascular disease (EXCEPT: symptomatic cardiovascular disease such as stroke, angina pectoris, heart failure, myocardial infarction, OR revascularisation surgery in the last 12 months at pre-screening) (1 point)
Exclusion criteria
Exclusion criteria: - Food allergies or other issues with the vitamins included in the supplement - Concurrent participation in other intervention trials - Clinical diagnosis of >=1 of the following: > Stroke; > Neurological disease(s) (e.g. MCI, dementia, MS, Parkinson's, epilepsy); > Current malignant disease(s), with or without treatment; > Current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes, eating disorder); > Symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction); > Revascularisation surgery in the last 12 months at pre-screening; > - Gastrointestinal diseases (i.e., diarrhoea, Crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers) or having a history of gastrointestinal surgical events (e.g. stoma) that may influence the results of the study, as determined by the study team; > Visual impairment (e.g. blindness); > Hearing or communicative impairment. - Use of antibiotics within the previous 3 months. - Use of protonpump inhibitors within the study period (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) - Not willing to refrain from taking other supplements (containing vitamin B2, B3, B6, B9, or C, prebiotic, or probiotic) that can interfere with the study outcomes, from at least 2 weeks before start of the intervention till the end of the intervention period. - Answering "Yes" on >=1 of the Donders Institute MRI safety screening protocol questions (see 8 questions below): 1. Are there metal objects located in your upper body? Exception: tooth-fillings and/or dental crowns. 2. Are there metal splinters in your body, in particular within the eyes? For example: through labour work in the metal industry. 3. Are there jewellery items or piercings that you are unable to take off? 4. Have you had a brain surgery in the past? 5. Are there active implants present? For example: pacemaker, neurostimulator, insulinpump, hearing aid (that is unable to be removed). 6. Are there any medical plasters or patches that you can*t or may not take off? For example: nicotine patch. 7. Do you suffer from epilepsy? 8. Do you suffer from claustrophobia? - Cognitive impairment as determined by Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion and defined as a score <23.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are baseline (before week 1) and follow-up (after week 6) measures of (1) BOLD activity and task accuracy during N-back fMRI task (2) Total faecal SCFA concentration measured by gas chromatograph mass spectrometry | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters include (1) Additional neuroimaging measures (e.g. MRS: myo-inositol levels reflecting neuroinflammation, QSM: intracranial iron-deposits, and ASL: cerebral perfusion levels) (2) Faecal analysis (e.g. microbiota composition and abundance, individual SCFA concentrations, water content, pH, redox potential, inflammatory markers, vitamin concentrations) (3) Plasma analysis (e.g. inflammatory markers, intestinal integrity markers, redox markers, SCFA concentrations, metabolic markers, brain markers, vitamin concentrations) and Urine analysis (vitamin concentrations) (4) Z-scoring on cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed. | — |
Countries
Netherlands
Outcome results
None listed