Well-being/Quality of LifeNCT07740135
Neurophysiological Effects of Daily Centrum Use on Mood and Well-Being: A Cognalyzer EEG Analysis in Adults Between 40-60
An observational study of Well-being/Quality of Life, run by Zentrela Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being/Quality of Life
- What is being tested?
- Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2026to 30 Nov 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults 40-60
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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:
- Does daily use of the multivitamin over a 12 week period improve well-being indicators as measured using EEG-based and subjective mood tests?
- Does perturbation in mood effects due to cognitive load after a battery of cognitive assessments improve after 12 weeks of multivitamin intake.
Read the 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.
- Conditions
- Well-being/Quality of Life
- Being tested
- Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451
- Keywords
- EEG, well-being, machine learning, nutrition, vitamins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451Dietary supplement
Dosage 1 pill per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Daily multivitamin intake group | Not described Receives: Dietary Supplement: Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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; 250 Hz, 24 bit). 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.
Measured: 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.
Measured: Comparison after 12 weeks of product use.
Secondary outcomes (4)
EEG-derived Arousal Effect Level (AEL)
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.
Measured: Comparison after 12 weeks of product use.
BRUMS Self-reported Mood Test
BRUMS self-report compared between baseline and post product-use visits, before and after cognitive tests.
Measured: Comparison after 12 weeks of product use.
EEG-derived Valence Effect Level (VEL), indicative of genreal positive or negative mood.
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.
Measured: Comparison after 12 weeks of product use.
EEG-derived Anxiety Effect Level (AXL)
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.
Measured: Comparison after 12 weeks of product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start20 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-being/Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Zentrela Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HALEON
- Responsible party
- Sponsor
- Investigators
- Dan Bosnyak, PhD, Principal investigator, Zentrela Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740135
- Sponsor's protocol ID
- CUSIC-85
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study is being conducted for a private client.
Publications
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.
PubMed 33826089
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07740135
- Acronym / sponsor ID
- CUSIC-85
- Conditions
- Well-being/Quality of Life
- Keywords
- EEG, well-being, machine learning, nutrition, vitamins
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zentrela Inc.Industry (pharma, biotech, devices)
- Collaborators
- HALEON
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does daily use of the multivitamin over a 12 week period improve well-being indicators as measured using EEG-based and subjective mood tests?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily multivitamin intake group | – | Dietary Supplement: Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults 40-60
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centrum Silver Adult Multivitamin UPC 62107535670 NPN 80141451Dosage 1 pill per day for 12 weeks | Dietary supplement | Daily multivitamin intake group |
Primary outcome
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; 250 Hz, 24 bit). 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)
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.
4 secondary outcomes
EEG-derived Arousal Effect Level (AEL)
Time frame: Comparison after 12 weeks of product use.
BRUMS Self-reported Mood Test
Time frame: Comparison after 12 weeks of product use.
EEG-derived Valence Effect Level (VEL), indicative of genreal positive or negative mood.
Time frame: Comparison after 12 weeks of product use.
EEG-derived Anxiety Effect Level (AXL)
Time frame: Comparison after 12 weeks of product use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 33826089McDonald 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.
- Individual participant dataSharing planned: No. Study is being conducted for a private client.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Bosnyak, PhD principal investigator
Zentrela Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-being/Quality of Life, run by Zentrela Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG-Derived Relaxation Level (REL) (time frame: Comparison after 12 weeks of product use.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07740135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.