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Enrolling by Invitation

NCT Number: NCT07740135

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

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. 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. Does perturbation in mood effects due to cognitive load after a battery of cognitive assessments improve after 12 weeks of multivitamin intake.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentrela Inc Canadian Office

Hamilton, Ontario, L8P 1J4, Canada

About this study

This was a prospective, single-arm, observational study evaluating the effects of regular use of a Centrum multivitamin on mood, measured with subjective questionnaires and neurophysiological responses in adults between 40-60.

Participants were recruited from a large group who participated in a 5 day nutritional intake monitoring program (ASA24®, https://epi.grants.cancer.gov/asa24/). The participants with the lowest scores on the ASA evaluation were selected to participate in the study. All participants provided written informed consent before any study procedures.

The study consisted of two visits: a baseline visit (EEG, questionnaires), a period of 12 weeks of daily multivitamin use, followed by a second visit assessing extended effects of product use. Daily monitoring and weekly questionnaires continued throughout the product intake period.

EEG recordings were analyzed using Cognalyzer® EEG-based metrics, including mood valence, relaxation, and mental arousal. The primary objective was to evaluate changes in neurophysiological and self-reported measures of stress and relaxation both before and after a battery of cognitive assessments; exploratory objectives included a variety of other well-being measures measured both using EEG and standardized psychometric tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Centrum Silver Adult Multivitamin UPC 62107535670

Dietary Supplement

Dosage 1 pill per day for 12 weeks

Primary outcomes

  1. Change in EEG-Derived Relaxation Level (REL)

    Time frame: Comparison after 12 weeks of product use.

    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.

  2. Change in EEG-Derived Mental Confusion Level (COL)

    Time frame: Comparison after 12 weeks of product use.

    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.

Secondary outcomes

  1. EEG-derived Arousal Effect Level (AEL)

    Time frame: Comparison after 12 weeks of product use.

    AEL is a continuous, algorithmically derived index of arousal 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 arousal ratings uses a fixed feature subset (mRMR/LightGBM selection) to output one score per segment, from -10 (least aroused) to +10 (most aroused); higher scores indicate greater arousal. 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 AEL minus mean pre-task AEL within a session, and the two sessions will be compared.

  2. BRUMS Self-reported Mood Test

    Time frame: Comparison after 12 weeks of product use.

    BRUMS self-report compared between baseline and post product-use visits, before and after cognitive tests.

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

    Time frame: Comparison after 12 weeks of product use.

    VEL is a continuous, algorithmically derived index of mood valence 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 mood ratings uses a fixed feature subset (mRMR/LightGBM selection) to output one score per segment, scores range from -10 to +10: negative values indicate negative (unpleasant) mood, positive values indicate positive (pleasant) mood. 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 VEL minus mean pre-task VEL within a session, and the two sessions will be compared.

  4. EEG-derived Anxiety Effect Level (AXL)

    Time frame: Comparison after 12 weeks of product use.

    AXL is a continuous, algorithmically derived index of anxiety 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 anxious) to +10 (most anxious); higher scores indicate greater anxiety. 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 AXL minus mean pre-task AXL within a session, and the two sessions will be compared.

Sponsors and collaborators

Lead sponsor

Zentrela Inc.

Industry

Collaborators

  • HALEON

Registry information

Official study title

Mood and Well-Being Following 12 Weeks of Daily Centrum Silver Multivitamin Supplementation in Adults Between 40-60: A Neurophysiological EEG Study Using the Cognalyzer EEG Analysis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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