Role of Centrum® Silver® in Improving Micronutrient Status in Older Men

June 4, 2025 updated by: Tory Hagen, Oregon State University
Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and have an increased demand for many of these micronutrients. Multivitamin/multimineral supplement offer a simple way for adults to improve nutrient intake, but their ability to measurably affect micronutrient status in older adults has never been explored. This study intends to recruit healthy, non-smoking men aged 65 years or older. After meeting entry criteria, subjects will be required to restrict the use of supplements and/or fortified foods. Two months after these restrictions have begun, subjects will come to the clinical research center to take cognitive tests, undergo activity monitoring, provide blood samples for nutrition testing, and take food frequency questionnaires. Subjects will then be randomized into one of two groups - one consuming a multivitamin/multimineral supplement (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will consume 1 tablet each day for six months. After this period, subjects will return to the clinical research center and repeat cognitive tests, activity monitor, blood sampling, and food frequency questionnaires. These data will be assessed to determine if multivitamin consumption results in changes in various nutrients versus taking a placebo (primary outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health, inflammation, blood pressure or cognitive function (secondary outcomes). The investigators expect that results of this study will add to the general understanding if multivitamin/multimineral formulas can improve nutrition status of older adults, and therefore have the capacity of altering markers of health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Older adults are at increased risk of various chronic diseases, in which inadequate levels of vitamins and minerals may play a significant role, including cardiovascular disease, Alzheimer's disease, liver disease, and cancer. Most adults in the United States do not meet the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) of many vitamins and nutritionally-essential minerals from diet alone, including vitamins A, C, D, E and K, calcium, magnesium, and potassium. Older adults are particularly susceptible to micronutrient inadequacies because of limited absorption, increased requirements, or - in the case of vitamin D - decreased synthetic capacity in the skin. Thus, there is a strong rationale for supplementing the diets of older adults with a multivitamin/multimineral supplement, such as Centrum® Silver®. However, little is currently known about the bioavailability of the Centrum® Silver® formula in this age demographic.

Epidemiological studies and recent clinical trials have shown that use of multivitamin/mineral supplements has beneficial effects on disease risk in men, including those of advanced age. It is assumed that these benefits of multivitamin/mineral supplements are achieved through changes in nutrition status. However, it has never been documented if there are concomitant changes in micronutrient levels in individuals who consume these supplements. Furthermore, changes in nutritional status in older individuals taking multivitamin/multimineral supplements are a subject that has yet to be explored.

Therefore, this study seeks to recruit men who are in generally good health, 65 years of age or older, to assess their vitamin and mineral status before and after six months (approximately 24 weeks) of supplementation with Centrum® Silver®. The investigators hypothesize that consuming multivitamin/multimineral supplements everyday will result in measurable increases in the status of one or more vitamins or minerals in the body. Concentrations of several vitamins and minerals in blood samples will be performed, along with a general assessment of micronutrient status in white blood cells (primary outcomes). To see if these changes in nutrition status impact other aspects of human health, changes in lipid and lipoprotein profiles, antioxidant status, metabolic health, and inflammation and treatment differences in cognitive function will be assessed (secondary outcomes). Centrum® Silver® supplementation may or may not have any effect on these secondary outcomes, when compared to a placebo, unless there are measurable changes in the primary outcomes.

The expectation is that the results of this research will add to a general understanding of multivitamin/mineral supplements and how well they can improve the nutritional status of older adults. By employing direct and functional methods to assay for nutritional content, this study will determine how well these methods correlate and by using both assay methods unique insight into the mechanism(s) whereby multivitamin/multimineral supplements might or might not lead to improvements in health may be ascertained.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Linus Pauling Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Participants must be willing to:

  • Consume a multivitamin/mineral supplement or placebo tablet each day during the 6-month study period
  • Fill out online food frequency questionnaires
  • Refrain from taking vitamin and mineral supplements that match micronutrients found in Centrum Silver (including certain antacids, energy drinks, fortified cereals, or nutritional shakes) other than those provided during the study. . Current users of supplements must agree to stop taking these supplements for two months before the study begins.
  • Wear an activity monitor about the wrist continuously for two one-week periods, except when exposed to water, before and during multivitamin supplementation.
  • Give blood samples on 3 separate occasions
  • Participate in cognitive testing procedures

Exclusion Criteria:

  • Currently taking supplements as recommended/ordered by a physician to correct a nutritional deficiency, with an exception for vitamins or minerals not found in Centrum Silver (as outlined in a Post-Screen Drug and Supplement Review).
  • Current or recent (two years) history of smoking (tobacco or marijuana)
  • Dysphagia or difficulty swallowing.
  • Bariatric (gastric bypass) surgery or serious chronic illness that might affect absorption of multivitamins or minerals such as Crohn's disease, unmanaged celiac disease, chronic diarrhea, ulcerative colitis, gastritis, or a diagnosis of malabsorption syndrome.
  • A diagnosis of cancer with chemotherapy or radiation treatment during the previous 5 years.
  • Major surgery in the past 6 months or planned major surgery during the duration of the study.
  • Prior heart attack, stroke, or heart failure.
  • Uncontrolled stage II hypertension (blood pressure above 159/99 mm Hg).
  • A current diagnosis of kidney, liver, or thyroid disease.
  • Diabetes (Type 1 or Type 2).
  • History of hypoglycemia or low blood sugar.
  • Hb1ac levels > 6.4%.
  • Fail a Post-Screen Drug and Supplement Review.
  • BMI < 18.5 or > 35
  • History of psychological or neurological disorders, or a diagnosis of dementia.
  • Head injury with loss of consciousness of > 5 minutes in the last 5 years.
  • Chronic Migraines - More than fifteen headache days per month over a three-month period of which more than eight are migraines.
  • Score < 26 on the mini-mental state exam.
  • Present treatment for drug or alcohol problems.
  • Habit of taking three or more alcoholic drinks per day.
  • Corrected visual acuity worse than 20/50.
  • Anyone who cannot handwrite a letter or move a computer joystick with one of their hands.
  • Cannot hear well enough to understand spoken instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multivitamin
Centrum Silver Men's Formula Multivitamin/Multimineral Supplement: 1/day
Dietary supplement: Centrum Silver Mens' Formula
Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.
Other Names:
  • Centrum Silver Men
Placebo Comparator: Control
Matching tablet to active multivitamin arm: 1/day
Other: Control
A matching tablet to the dietary supplement, but without any active ingredients
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Plasma and Blood Cell Vitamin and Mineral Levels
Time Frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
Blood samples will be collected at baseline and end of intervention. Plasma levels of beta carotene, pyridoxine (vitamin B6), cobalamin (vitamin B12), ascorbic acid (vitamin C), 25-hydroxy vitamin D, α- tocopherol (vitamin E), and phylloquinone/menaquinones (vitamin K) will be determined. Analyses will be performed for absolute values and values corrected for total lipids where necessary. Folate will be assessed in red blood cells. Minerals analysis by inductively coupled plasma atomic emission spectroscopy (ICP-AES) will be performed in plasma or lymphocytes.
Between baseline (visit 3) and 6 months after intervention begins (visit 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lipid Status
Time Frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
Changes to fasting lipoprotein and triglyceride status
Between baseline (visit 3) and 6 months after intervention begins (visit 7)
High Resolution Respirometry
Time Frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
Isolated white blood cells will be evaluated in the Oroboros Oxygraph (Innsbruck, Austria) to evaluate the capacity of mitochondria to sustain respiration/energy demands
Between baseline (visit 3) and 6 months after intervention begins (visit 7)
Cognitive abilities
Time Frame: Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)
Cognitive abilities will be assessed by the following NIH Toolbox measures: Picture Vocabulary, Flanker Inhibitory Control and Attention Test, Sorting Working Memory Test, Dimensional Change Card Sort Test, Pattern Completion Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition Test. The individual test scores are based on time and accuracy, will be normalized to scaled scores, and averaged to obtain a Fluid Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded. Logical Memory will be tested with recall of narrative story both immediate and delayed as described in Wechsler Memory Scale-IV Protocol. Additionally, a "Head-Toes-Knees-Shoulders Task" that combines physical activity with processing speed and accuracy will also be assessed at the completion of each session.
Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)
Spatial memory as assessed by a virtual water maze
Time Frame: At visit 6, approximately 6 months after intervention begins, 1 week before visit 7
A computerized environment will be presented for the subject that can be navigated with a joystick. The goal is to find a hidden platform based on spatial clues. Search accuracy for the target platform in the environment will be assessed between trials. Changes in proximity to the platform will be compared between successive trials in an individual, and also between individuals in the placebo control and multivitamin intervention groups.
At visit 6, approximately 6 months after intervention begins, 1 week before visit 7
Crystallized cognitive abilities
Time Frame: 1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)
Crystallized abilities will be assessed with NIH Toolbox Oral Reading Recognition Test and NIH Toolbox Picture Vocabulary Test. The individual test scores will be determined after adjusting for computer adaptive testing, normalized to scaled scores, and averaged to obtain a Crystallized Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded.
1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activity Monitoring
Time Frame: Between visit 2 and visit 3 (duration: 1 week) and visit 6 and visit 7 (duration: 1 week)
Wrist activity monitors (FitBit, commercial model) will be worn by subjects at the given intervals. General activity level, calories burned, heart rate, and steps taken will be recorded to give a general assessment of "energy level".
Between visit 2 and visit 3 (duration: 1 week) and visit 6 and visit 7 (duration: 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tory M Hagen, PhD, Oregon State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WI211838
  • 7158 (Other Identifier: Oregon State University IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals and will be reviewed by study investigators.

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

Project proposal form sent to the Linus Pauling Institute

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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