Zentrela Inc Canadian Office
Hamilton, Ontario, L8P 1J4, Canada
NCT Number: NCT07740135
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.
Interested in participating?
Request Info40 year–60 year
All sexes
Observational
Hamilton, Ontario, L8P 1J4, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dosage 1 pill per day for 12 weeks
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.
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.
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.
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.
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.
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.
Zentrela Inc.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)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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