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Effects of a Colon-delivered Multivitamin Supplement on Brain Functioning, Immunometabolic- and Intestinal Markers in Ageing (COMBI)

Primary Purpose

Cognitive Decline, Aging

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Colon-delivered multivitamin supplement
Placebo capsule
Sponsored by
Donders Centre for Cognitive Neuroimaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Decline focused on measuring Intestinal health, Gut-brain axis

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent Age between 60-75 years (at pre-screening) Fluency in Dutch (speaking, reading and writing) Score ≥2 points on the risk factor scale below based on self report: BMI≥25 (1 point) Physical inactivity (according to WHO guidelines) (1 point) Hypertension (1 point) Hypertension without medication (1 point) Hypercholesterolemia (1 point) Diabetes type II (1 point) Mild cardiovascular disease (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 before the study start. 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 the 8 questions below): Are there metal objects located in your upper body? Exception: tooth-fillings and/or dental crowns. Are there metal splinters in your body, in particular within the eyes? For example: through labour work in the metal industry. Are there jewellery items or piercings that you are unable to take off? Have you had a brain surgery in the past? Are there active implants present? For example: pacemaker, neurostimulator, insulin pump, hearing aid (that is unable to be removed). Are there any medical plasters or patches that you can't or may not take off? For example: nicotine patch. Do you suffer from epilepsy? 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.

Sites / Locations

  • Radboud University, Donders Centre for Cognitive NeuroimagingRecruiting
  • Wageningen University and Research, Division of Human Nutrition and HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colon-delivered multivitamin supplement

Placebo

Arm Description

Within this arm, study subjects will consume a colon-delivered multivitamin supplement for 6 weeks. Subjects are instructed to consume the capsule daily during breakfast. The capsule must be taken orally with a glass of water.

Within this arm, study subjects will consume a placebo capsule for 6 weeks. Subjects are instructed to consume the capsule daily during breakfast. The capsule must be taken orally with a glass of water.

Outcomes

Primary Outcome Measures

Change in brain activity during working memory
Blood-oxygen level dependent activity in dlPFC and hippocampus during N-back fMRI task
Change in working memory performance
Task accuracy during N-back fMRI task
Change in faecal short-chain fatty acids
Total faecal short-chain fatty acid concentration measured by gas chromatograph mass spectrometry

Secondary Outcome Measures

Change in brain myo-inositol levels (neuroimaging)
Brain myo-inositol levels reflecting neuroinflammation in dlPFC and hippocampus, measured by magnetic resonance spectroscopy
Change in cerebral perfusion levels (neuroimaging)
Cerebral perfusion levels measured by arterial spin labelling
Change in neuropsychological test-battery scoring
Z-scoring on cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed.
Change in microbiota profile (faecal)
16S rRNA based profile of gut microbiota in faeces
Change in individual short-chain fatty acids profile (faecal)
GCMS measurement to assess profile of individual SCFAs in faeces (acetic acid, formic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, 4-methyl valeric acid, hexanoic acid, heptanoic acid)
Change in stool water content (faecal)
Water content of stool, based on wet- and dry weight.
Change in stool pH (faecal)
Faecal pH will be measured with a pH/redox meter in faeces
Change in stool redox potential (faecal)
Redox potential will be measured with a pH/redox meter in faeces
Change in intestinal inflammation profile (faecal)
Assay-based profile of intestinal inflammation measured in faeces
Change in C-reactive protein concentration (blood)
hsCRP measured via finger prick analysis
Change in white blood cell count (blood)
White blood cell count measured via finger prick analysis
Change in inflammation profile (blood)
Assay-based profile of systemic inflammation measured in plasma
Change in intestinal integrity profile (blood)
Assay-based profile of intestinal integrity measured in plasma
Change in anti-oxidant status profile (blood)
Assay-based profile of anti-oxidant status and oxidative stress measured in plasma
Change in metabolic profile (blood)
Assay-based profile of (energy) metabolism measured in plasma
Change in brain health profile (blood)
Assay-based profile of brain health measured in plasma
Change in vitamin profile (blood)
Assay-based profile of circulating vitamins from supplement measured in plasma

Full Information

First Posted
October 24, 2022
Last Updated
September 6, 2023
Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Wageningen University and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05675007
Brief Title
Effects of a Colon-delivered Multivitamin Supplement on Brain Functioning, Immunometabolic- and Intestinal Markers in Ageing
Acronym
COMBI
Official Title
The Effects of a Colon-delivered Multivitamin Supplement on Brain Functioning and Its Relation With Immunometabolic and Intestinal Markers in Ageing: the COMBI Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Wageningen University and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
COMBI is a multi-center, randomized controlled trial among 70 older adults at risk of cognitive decline. The main goal is to investigate the effect of a 6-week colon-delivered multivitamin supplementation on the gut-brain axis in older adults, by assessing changes in brain function as well as intestinal changes compared to placebo.
Detailed Description
Growing evidence indicates an important role for intestinal health in development of cognitive decline in ageing. Intestinal health, and especially the gut microbiome, is assumed to affect brain health and functioning via immunometabolic pathways captured in the gut-brain axis. However, it is unclear whether changes in intestinal health markers causally relate to cognitive decline in older adults and how. Nutritional interventions specifically targeting the gut were found beneficial for human cognition and brain function. An intervention based on colon-delivered vitamins (B2, B3, B6, B9, C, D3) is proposed to affect gut health using microbiome-dependent and independent pathways. In this study, it will be investigated whether this intervention affects neurocognition in ageing humans, to reveal causal gut-brain relationships in aging.Therefore, the primary goal of the COMBI study is to investigate the effect of a 6-week colon-delivered multivitamin supplementation on the gut-brain axis in older adults, by assessing changes in brain function as well as intestinal changes compared to placebo. Secondary, the effects of this 6-week colon-delivered multivitamin supplementation in older adults on the following parameters related to potential gut-brain pathways will also be investigated: (1) other relevant brain parameters, (2) other relevant intestinal parameters, (3) immunometabolic parameters related to gut-brain pathways, and (4) neuropsychological test battery scoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Aging
Keywords
Intestinal health, Gut-brain axis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized controlled trial has two parallel intervention arms. One group will daily consume a colon-delivered multivitamin supplement for 6 weeks. The other group will daily consume a placebo tablet for 6 weeks. Participants will we randomly assigned to one of the two groups.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Stratified 1 to 1 randomization will be automatically performed in Castor. Participant, Investigator and Outcome Assessor will not be aware of the treatment group. An independent researcher will have access to randomization details, and make sure the participant will receive the correct supplement type.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colon-delivered multivitamin supplement
Arm Type
Experimental
Arm Description
Within this arm, study subjects will consume a colon-delivered multivitamin supplement for 6 weeks. Subjects are instructed to consume the capsule daily during breakfast. The capsule must be taken orally with a glass of water.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Within this arm, study subjects will consume a placebo capsule for 6 weeks. Subjects are instructed to consume the capsule daily during breakfast. The capsule must be taken orally with a glass of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Colon-delivered multivitamin supplement
Intervention Description
Colon-delivered multivitamin supplement containing the following dose of the indicated vitamin: vitamin B2 (10 mg), vitamin B3 (4.0 mg), vitamin B6 (1.4 mg), vitamin B9 (400 μg), vitamin C (200 mg) and vitamin D3 (15ug). Vitamin capsules are filled with microcrystalline cellulose and magnesium stearate up to 200 mg. Control of release in the colon is achieved by the Eudragit S 100 coating layer technology that surrounds the vitamins contained in the core capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsule
Intervention Description
Placebo capsule containing microcrystalline cellulose and magnesium stearate up to 200 mg. Placebo capsules are coated with the Eudragit S 100 coating layer.
Primary Outcome Measure Information:
Title
Change in brain activity during working memory
Description
Blood-oxygen level dependent activity in dlPFC and hippocampus during N-back fMRI task
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in working memory performance
Description
Task accuracy during N-back fMRI task
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in faecal short-chain fatty acids
Description
Total faecal short-chain fatty acid concentration measured by gas chromatograph mass spectrometry
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Secondary Outcome Measure Information:
Title
Change in brain myo-inositol levels (neuroimaging)
Description
Brain myo-inositol levels reflecting neuroinflammation in dlPFC and hippocampus, measured by magnetic resonance spectroscopy
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in cerebral perfusion levels (neuroimaging)
Description
Cerebral perfusion levels measured by arterial spin labelling
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in neuropsychological test-battery scoring
Description
Z-scoring on cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed.
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in microbiota profile (faecal)
Description
16S rRNA based profile of gut microbiota in faeces
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in individual short-chain fatty acids profile (faecal)
Description
GCMS measurement to assess profile of individual SCFAs in faeces (acetic acid, formic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, 4-methyl valeric acid, hexanoic acid, heptanoic acid)
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in stool water content (faecal)
Description
Water content of stool, based on wet- and dry weight.
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in stool pH (faecal)
Description
Faecal pH will be measured with a pH/redox meter in faeces
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in stool redox potential (faecal)
Description
Redox potential will be measured with a pH/redox meter in faeces
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in intestinal inflammation profile (faecal)
Description
Assay-based profile of intestinal inflammation measured in faeces
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in C-reactive protein concentration (blood)
Description
hsCRP measured via finger prick analysis
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in white blood cell count (blood)
Description
White blood cell count measured via finger prick analysis
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in inflammation profile (blood)
Description
Assay-based profile of systemic inflammation measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in intestinal integrity profile (blood)
Description
Assay-based profile of intestinal integrity measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in anti-oxidant status profile (blood)
Description
Assay-based profile of anti-oxidant status and oxidative stress measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in metabolic profile (blood)
Description
Assay-based profile of (energy) metabolism measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in brain health profile (blood)
Description
Assay-based profile of brain health measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in vitamin profile (blood)
Description
Assay-based profile of circulating vitamins from supplement measured in plasma
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Other Pre-specified Outcome Measures:
Title
Body mass index
Description
Measured in kg/m^2
Time Frame
Baseline (T0)
Title
Waist circumference
Description
Measured in cm
Time Frame
Baseline (T0)
Title
Hip circumference
Description
Measured in cm
Time Frame
Baseline (T0)
Title
Blood pressure
Description
Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Time Frame
Baseline (T0)
Title
Abdominal fat distribution
Description
VAT(visceral adipose tissue)/SAT(subcutaneous adipose tissue) ratio based on abdominal MRI scan
Time Frame
Baseline (T0)
Title
Baseline Demographics and medical history (questionnaire)
Description
Demographic information, medical history and medication use - qualitative assessment
Time Frame
Baseline (T0)
Title
4DKL (questionnaire)
Description
(Psychosocial) complaints in daily life. Separate scores for distress (>10 moderate, >20 severe), depression (>2 moderate, >5 severe), anxiety (>3 moderate, >9 severe) and somatisation (>10 moderate, >20 severe)
Time Frame
Baseline (T0)
Title
EQ-5D-5L (questionnaire)
Description
Quality of life. Scores range from 0-100, higher scores indicate better quality of life
Time Frame
Baseline (T0)
Title
Five Facet Mindfulness Questionnaire (questionnaire)
Description
Self-assessment of mindfulness. Total scale ranges from 24 - 120, higher scores indicate more mindfulness
Time Frame
Baseline (T0)
Title
LIBRA (questionnaire)
Description
Modifiable dementia risk using lifestyle for brain health. The score ranges from -5.9 (minimum score) to +12.7 (maximum score), with higher scores meaning a worse outcome (higher dementia risk)
Time Frame
Baseline (T0)
Title
Lubben Social Network Scale (questionnaire)
Description
Social contact and perceived social support. The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)
Time Frame
Baseline (T0)
Title
SARC-F Sarcopenia questionnaire (questionnaire)
Description
Sarcopenia. Scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).
Time Frame
Baseline (T0)
Title
Sedentary Behaviour Questionnaire (questionnaire)
Description
Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.
Time Frame
Baseline (T0)
Title
Change in Nutritional intake (questionnaire)
Description
Nutritional intake measured with a Food Frequency Questionnaire, assessing food intake of the past month, qualitative assessment
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Perceived Stress Scale (questionnaire)
Description
Stress perception. Total score, scale 0 - 40, higher scores indicate more perceived stress
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Description
Sleep quality. Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in SQUASH (questionnaire)
Description
Physical activity. METs derived from the Ainsworth's compendium of physical activity will be used to classify physical activity intensity (<1.5METs- sedentary, 1.6-2.9 METs- light, 3.0-5.9METs- moderate, >6.0- vigorous physical activity).
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Gastrointestinal symptoms questionnaire (questionnaire)
Description
Gastrointestinal symptoms, qualitative assessment
Time Frame
Baseline (T0)
Title
Gastrointestinal symptoms questionnaire (questionnaire)
Description
Gastrointestinal symptoms, qualitative assessment
Time Frame
Follow-up after 6 weeks (T1)
Title
Bristol stool chart (questionnaire)
Description
Classification of faeces type, qualitative assessment
Time Frame
Baseline (T0)
Title
Bristol stool chart (questionnaire)
Description
Classification of faeces type, qualitative assessment
Time Frame
Follow-up after 6 weeks (T1)
Title
Gut transit time
Description
Gut transit time measured by blue muffin consumption and appearance in faeces
Time Frame
Baseline (T0)
Title
Gut transit time
Description
Gut transit time measured by blue muffin consumption and appearance in faeces
Time Frame
Follow up after 6 weeks (T1)
Title
Change in Cognitive Failures Questionnaire (questionnaire)
Description
Subjective cognitive functioning. Score ranges from 0-100. A higher total score indicates more subjective cognitive failure.
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Cognitive Emotions Regulation Questionnaire (questionnaire)
Description
Cognitive coping strategies. Answers are scored on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores in each subscale of cognitive reappraisal and expressive suppression
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Hospital Anxiety and Depression Scale (questionnaire)
Description
Anxiety and depression. Separate scores for anxiety (max 21) and depression (max 21). For each domain, a score >8 indicates psychiatric condition of anxiety or depression.
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Memory Self-Efficacy MIA (questionnaire)
Description
Self-evaluation and confidence of memory. Sum of Part 1 + Part 2A and B. Part 1: Strategy (scores 10 - 50, higher scores indicate more use of strategies), Part 2A: Subjective memory functioning, scores ranges from 23 - 115, with higher scores indicate better memory self-efficacy and 2B: Locus, scores ranges from 7 - 35, higher scores indicate better perceived personal control over remembering abilities.
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
Change in Starkstein Apathy Scale (questionnaire)
Description
Screen and measure apathetic symptoms. A higher total score (range 0-42) indicates more severe apathy, with a score greater than 14 or greater is indicative of clinical apathy
Time Frame
Change between Baseline (T0), Follow-up after 6 weeks (T1)
Title
User experiences (questionnaire)
Description
User experiences of the supplement - qualitative assessment.
Time Frame
Follow up after 6 weeks (T1)
Title
COVID status (questionnaire)
Description
Vaccination status, COVID history - qualitative assessment.
Time Frame
Baseline (T0)
Title
COVID status (questionnaire)
Description
Vaccination status, COVID history - qualitative assessment.
Time Frame
Follow up after 6 weeks (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent Age between 60-75 years (at pre-screening) Fluency in Dutch (speaking, reading and writing) Score ≥2 points on the risk factor scale below based on self report: BMI≥25 (1 point) Physical inactivity (according to WHO guidelines) (1 point) Hypertension (1 point) Hypertension without medication (1 point) Hypercholesterolemia (1 point) Diabetes type II (1 point) Mild cardiovascular disease (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 before the study start. 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 the 8 questions below): Are there metal objects located in your upper body? Exception: tooth-fillings and/or dental crowns. Are there metal splinters in your body, in particular within the eyes? For example: through labour work in the metal industry. Are there jewellery items or piercings that you are unable to take off? Have you had a brain surgery in the past? Are there active implants present? For example: pacemaker, neurostimulator, insulin pump, hearing aid (that is unable to be removed). Are there any medical plasters or patches that you can't or may not take off? For example: nicotine patch. Do you suffer from epilepsy? 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lianne B. Remie, MSc
Phone
0031024366388
Email
lianne.remie@donders.ru.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Aarts, prof. dr.
Organizational Affiliation
Radboud University, Donders Centre for Cognitive Neuroimaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University, Donders Centre for Cognitive Neuroimaging
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 EN
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianne B. Remie, MSc
Phone
0031634515156
Email
lianne.remie@donders.ru.nl
Facility Name
Wageningen University and Research, Division of Human Nutrition and Health
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilma T. Steegenga, dr.
Phone
0031317485181
Email
wilma.steegenga@wur.nl

12. IPD Sharing Statement

Learn more about this trial

Effects of a Colon-delivered Multivitamin Supplement on Brain Functioning, Immunometabolic- and Intestinal Markers in Ageing

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