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

NCT05675007 | Completed

• 1 other identifier: 3033003.02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Decline; Aging

Keywords

Intestinal health; Gut-brain axis

Outcome Measures

Primary Outcomes (3)

• Change in brain activity during working memory

  Blood-oxygen level dependent activity in dlPFC and hippocampus during N-back fMRI task

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in working memory performance

  Task accuracy during N-back fMRI task

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in faecal short-chain fatty acids

  Total faecal short-chain fatty acid concentration measured by gas chromatograph mass spectrometry

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

Secondary Outcomes (17)

• Change in brain myo-inositol levels (neuroimaging)

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in cerebral perfusion levels (neuroimaging)

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in neuropsychological test-battery scoring

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in microbiota profile (faecal)

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

• Change in individual short-chain fatty acids profile (faecal)

  Change between Baseline (T0), Follow-up after 6 weeks (T1)

Other Outcomes (31)

• Body mass index

  Baseline (T0)

• Waist circumference

  Baseline (T0)

• Hip circumference

  Baseline (T0)

Study Arms (2)

Colon-delivered multivitamin supplement

EXPERIMENTAL

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.

Dietary Supplement: Colon-delivered multivitamin supplement

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo capsule

Interventions

Colon-delivered multivitamin supplement DIETARY_SUPPLEMENT

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.

Colon-delivered multivitamin supplement

Placebo capsule DIETARY_SUPPLEMENT

Placebo capsule containing microcrystalline cellulose and magnesium stearate up to 200 mg. Placebo capsules are coated with the Eudragit S 100 coating layer.

Placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Donders Centre for Cognitive Neuroimaging: lead
• Wageningen University and Research: collaborator

Study Sites (2)

Radboud University, Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, 6525 EN, Netherlands

Location

Wageningen University and Research, Division of Human Nutrition and Health

Wageningen, Gelderland, 6708 WE, Netherlands

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Esther Aarts, prof. dr.

  Radboud University, Donders Centre for Cognitive Neuroimaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: January 9, 2023
• Study Start: December 5, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-05

Locations

NL (2)