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

NCT03004807 | Completed

• 2 other identifiers: WI2118387158
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nutrition; Aging; Multivitamin

Outcome Measures

Primary Outcomes (1)

• Changes in Plasma and Blood Cell Vitamin and Mineral Levels

  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 Outcomes (5)

• Lipid Status

  Between baseline (visit 3) and 6 months after intervention begins (visit 7)

• High Resolution Respirometry

  Between baseline (visit 3) and 6 months after intervention begins (visit 7)

• Cognitive abilities

  Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)

• Spatial memory as assessed by a virtual water maze

  At visit 6, approximately 6 months after intervention begins, 1 week before visit 7

• Crystallized cognitive abilities

  1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)

Other Outcomes (1)

• Activity Monitoring

  Between visit 2 and visit 3 (duration: 1 week) and visit 6 and visit 7 (duration: 1 week)

Study Arms (2)

Multivitamin

EXPERIMENTAL

Centrum Silver Men's Formula Multivitamin/Multimineral Supplement: 1/day

Dietary Supplement: Centrum Silver Mens' Formula

Control

PLACEBO COMPARATOR

Matching tablet to active multivitamin arm: 1/day

Other: Control

Interventions

Centrum Silver Mens' Formula DIETARY_SUPPLEMENT

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

Also known as: Centrum Silver Men

Multivitamin

Control OTHER

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

Also known as: Placebo Comparator

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon State University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Linus Pauling Science Center

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

• Michels AJ, Butler JA, Uesugi SL, Lee K, Frei BB, Bobe G, Magnusson KR, Hagen TM. Multivitamin/Multimineral Supplementation Prevents or Reverses Decline in Vitamin Biomarkers and Cellular Energy Metabolism in Healthy Older Men: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2023 Jun 9;15(12):2691. doi: 10.3390/nu15122691.

  PMID: 37375594 BACKGROUND

MeSH Terms

Conditions

Avitaminosis

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Tory M Hagen, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 29, 2016
• Study Start: July 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study completion
• Access Criteria: Project proposal form sent to the Linus Pauling Institute

Locations

US (1)