Role of Centrum® Silver® in Improving Micronutrient Status in Older Men
NCT03004807
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Adult Trials: 18+ Years
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 dietary supplements (vitamins, minerals, certain antacids, energy drinks, fortified cereals, or nutritional shakes) other than those provided during the study, with an exception for vitamin D. Users of multivitamin supplements must agree to avoid taking these supplements for two months before the study begins.
- Refrain from taking acid-blockers during the course of the study.
- 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
- Currently taking supplements as recommended/ordered by a physician to correct a
nutritional deficiency, with an exception for vitamin D supplements
- 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%.
- Current use of certain drugs to control blood sugar, thyroid medications, anti-seizure
medication, anxiolytics, or antidepressants (see Post-Screen Drug 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.
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| Descriptive Information | |||||||||
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| Brief Title ICMJE | Role of Centrum® Silver® in Improving Micronutrient Status in Older Men | ||||||||
| Official Title ICMJE | Role of Centrum® Silver® in Improving Micronutrient Status in Older Men | ||||||||
| 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. | ||||||||
| 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Participants must be willing to:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 65 Years and older (Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03004807 | ||||||||
| Other Study ID Numbers ICMJE | WI211838 7158 ( Other Identifier: Oregon State University IRB ) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Tory Hagen, Oregon State University | ||||||||
| Study Sponsor ICMJE | Tory Hagen | ||||||||
| Collaborators ICMJE | GlaxoSmithKline | ||||||||
| Investigators ICMJE |
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| PRS Account | Oregon State University | ||||||||
| Verification Date | February 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||