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

Summary

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.

Conditions

• Vitamin Deficiency
• Mineral Deficiency
• Aging

Interventions

DIETARY_SUPPLEMENT

Centrum Silver Mens' Formula

Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.

OTHER

Control

A matching tablet to the dietary supplement, but without any active ingredients

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Oregon State University

  lead OTHER

Principal Investigators

• Tory M Hagen, PhD · Oregon State University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2021-05-31

Completion

2021-12-31

Countries

• United States

Study Locations