Well-being/Quality of Life
Conditions
Keywords
EEG, well-being, machine learning, nutrition, vitamins
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. 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCentrum Silver Adult Multivitamin UPC 62107535670
Dosage 1 pill per day for 12 weeks
Sponsors
Zentrela Inc.
HALEON
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EEG-Derived Relaxation Level (REL) | 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. |
| Change in EEG-Derived Mental Confusion Level (COL) | 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
| Measure | Time frame | Description |
|---|---|---|
| EEG-derived Arousal Effect Level (AEL) | 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. |
| BRUMS Self-reported Mood Test | Comparison after 12 weeks of product use. | BRUMS self-report compared between baseline and post product-use visits, before and after cognitive tests. |
| EEG-derived Valence Effect Level (VEL), indicative of genreal positive or negative mood. | 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. |
| EEG-derived Anxiety Effect Level (AXL) | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORDan Bosnyak, PhD
Zentrela Inc.
Outcome results
None listed