NL-OMON53665RecruitingNot Applicable
The effects of a colon-delivered multivitamin supplement on brain functioning and its relation with immunometabolic and intestinal markers in ageing: the COMBI study - COMBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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.
Investigators
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