Neurophysiological Effects of Daily Centrum Use on Mood and Well-Being: A Cognalyzer EEG Analysis in Adults Between 40-60

NCT07740135 | Enrolling By Invitation

• 1 other identifier: CUSIC-85
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether 12 weeks of use of Centrum® Silver Daily Multivitamin can improve mood, and overall well-being in older adults The main questions it aims to answer are:

1. 1.Does daily use of the multivitamin over a 12 week period improve well-being indicators as measured using EEG-based and subjective mood tests?
2. 2.Does perturbation in mood effects due to cognitive load after a battery of cognitive assessments improve after 12 weeks of multivitamin intake.

Conditions

Well-being/Quality of Life

Keywords

EEG; well-being; machine learning; nutrition; vitamins

Outcome Measures

Primary Outcomes (2)

• Change in EEG-Derived Relaxation Level (REL)

  Relaxation Effect Level (REL) is a continuous, algorithmically derived index of relaxation computed from a 2-minute resting EEG segment recorded at 8 scalp electrodes (Fp1, Fp2, T3, T4, P3, P4, O1, O2; Fz ref; 256 Hz). After automated artifact rejection, 200 features are computed across canonical frequency bands, including absolute and relative power spectral density, cross-power spectral density, and connectivity metrics (phase coherence). A support vector machine trained on an independent dataset of EEG labelled with concurrent subjective relaxation ratings uses a fixed feature subset (mRMR/LightGBM selection) to output one score per segment, from -10 (least relaxed) to +10 (most relaxed); higher scores indicate greater relaxation. Model and pipeline were locked prior to enrollment. Each session yields 2 pre-task and 2 post-cognitive-load segments; the reported value is mean post-task REL minus mean pre-task REL within a session, and the two sessions will be compared.

  Comparison after 12 weeks of product use.

• Change in EEG-Derived Mental Confusion Level (COL)

  COL is a continuous, algorithmically derived index of confusion computed from a 2-minute resting EEG segment recorded at 8 scalp electrodes (Fp1, Fp2, T3, T4, P3, P4, O1, O2; Fz ref; 256 Hz). After automated artifact rejection, 200 features are computed across canonical frequency bands, including absolute and relative power spectral density, cross-power spectral density, and connectivity metrics (phase coherence). A support vector machine trained on an independent dataset of EEG labelled with concurrent subjective confusion ratings uses a fixed feature subset (mRMR/LightGBM selection) to output one score per segment, from -10 (least confused) to +10 (most confused); higher scores indicate greater confusion. Model and pipeline were locked prior to enrollment. Each session yields 2 pre-task and 2 post-cognitive-load segments; the reported value is mean post-task COL minus mean pre-task COL within a session, and the two sessions will be compared.

  Comparison after 12 weeks of product use.

Secondary Outcomes (4)

• EEG-derived Arousal Effect Level (AEL)

  Comparison after 12 weeks of product use.

• BRUMS Self-reported Mood Test

  Comparison after 12 weeks of product use.

• EEG-derived Valence Effect Level (VEL), indicative of genreal positive or negative mood.

  Comparison after 12 weeks of product use.

• EEG-derived Anxiety Effect Level (AXL)

  Comparison after 12 weeks of product use.

Study Arms (1)

Daily multivitamin intake group

Dietary Supplement: Centrum Silver Adult Multivitamin UPC 62107535670

Interventions

Centrum Silver Adult Multivitamin UPC 62107535670 DIETARY_SUPPLEMENT

Dosage 1 pill per day for 12 weeks

Daily multivitamin intake group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults 40-60

You may qualify if:

• be between the ages of 40 to 60
• Answered affirmatively that they have consumed, or are interested in consuming the investigational product
• Willingness to comply with all study requirements, complete questionnaires, records, and assessments associated with the study and to complete the facility visit
• Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

• does not currently consume a multivitamin or dietary supplement that includes more than two micronutrients
• Women who are pregnant or breastfeeding
• Any objections that preclude the application of the EEG headset
• Allergy or sensitivity to any products required for the EEG measurement (e.g. conductive gel)
• Subjects with forehead skin/scalp health issues. (eg dermatitis, head lice, etc)
• History of a clinically significant adverse event associated with the consumption of a multivitamin product or any of its stated ingredients
• History of dementia, schizophrenia or other psychotic disorder, inclusive of alcohol or drug abuse within the last 12 months, interest or participation in drug abuse treatment within the past 60 days, or familial history of psychosis
• History of any clinically significant brain injury, based on self-report
• The participant is currently experiencing a migraine
• Significant cardiovascular event in the past 6 months
• Major surgery in the past 3 months
• Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
• Impairment from any drug or alcohol during their study visit, as assessed by the Principal Investigator or Sub-Investigator
• Individuals who are unable to give informed consent
• Any other condition that, in the opinion of the Principal Investigator or Sub-Investigator, may adversely affect the participant's ability to complete the study or its measures, or poses significant risk to the participant.

Sponsors & Collaborators

• Zentrela Inc.: lead
• HALEON: collaborator

Study Sites (1)

Zentrela Inc Canadian Office

Hamilton, Ontario, L8P 1J4, Canada

Location

Related Publications (1)

• McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M, Bosnyak D. Sensitivity, Specificity and Accuracy of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Detecting Cannabis Psychoactive Effects. Adv Ther. 2021 May;38(5):2513-2531. doi: 10.1007/s12325-021-01718-6. Epub 2021 Apr 7.

  PMID: 33826089 BACKGROUND

Study Officials

• Dan Bosnyak, PhD

  Zentrela Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)