CompletedNot Applicable

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

United States41 participantsStarted 2018-07-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Plasma and Blood Cell Vitamin and Mineral Levels

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

Trial details

NCT IDNCT03004807

SponsorOregon State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Vitamin Deficiency trials