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Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health

NCT ID: NCT03146312

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2017-06-08

Brief Summary

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This is a global transcriptomics and epigenetic pilot study designed to identify changes in gene expression and DNA methylation patterns following the consumption of an MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms underlying the health benefits associated with MVM/phytochemical supplementation.

Detailed Description

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There is considerable controversy regarding the benefit of widespread dietary supplement use, in particular widespread MVM use. The controversy persists because of a marked incongruity in nutrition research: on one hand, many studies indicate that MVM supplement consumption yields few - if any - demonstrable health benefits, yet on the other hand, numerous findings indicate most Americans do not consume the RDA of a variety of nutrients, particularly vitamins and minerals, and are becoming increasingly under-nourished. Nutrigenomics offers a unique opportunity to address this controversy, as it can identify subtle changes in gene expression and epigenetic signatures immediately following a nutritional intervention - changes which may be indicative of improved health status and which may otherwise remain undetectable through other clinical endpoints for a considerable period of time, even into future generations.

Hypothesis: The investigators hypothesize that MVM/phytochemical supplementation will result in transcriptional and epigenetic changes consistent with an enhancement in human health status. Moreover, the investigators hypothesize that MVM/phytochemical supplementation will alter markers of cardiovascular, antioxidant, nutritional as well as inflammatory status in a manner indicative of improved health.

Study Design:

This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 4-week period. 50-60 healthy subjects will be recruited and, if eligible for the study, matched by age, sex and ethnicity and randomized in a 1:1 ratio to either of two interventions:

1. Daily consumption of the control supplement (placebo)
2. Daily consumption of the MVM/phytochemical supplement (treatment)

Methods:

Blood will be collected at baseline and after the 4-week intervention. At each time point, PBMCs will be collected, and DNA and RNA extracted for genome-wide gene expression and DNA methylation analyses. Serum and plasma will also be collected in order to assess clinical markers related to cardiovascular, nutritional, antioxidant and inflammatory status.

Conditions

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Healthy

Keywords

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gene expression gene array epigenetics DNA methylation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MVM/phytochemical supplement

a multi-vitamin, multi-mineral, phytochemical supplement

Group Type EXPERIMENTAL

MVM/phytochemical supplement

Intervention Type DIETARY_SUPPLEMENT

Consumption of an MVM/phytochemical supplement for 4 weeks

Placebo

a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

Interventions

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MVM/phytochemical supplement

Consumption of an MVM/phytochemical supplement for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Provide a signed Informed Consent prior to entry in the study.
* Are in generally good health.
* Comprehensive Metabolic Panel results reported within normal reference ranges
* Body Mass Index of 18.5 - 30.
* Systolic blood pressure of 90-130 mm Hg; diastolic blood pressure of 60-90 mm Hg.
* Fasting blood glucose from 65-110 mg/dl.
* Total cholesterol level of \<240 mg/dl
* LDL cholesterol of \<130 mg/dl
* Triglyceride level of \<150 mg/dl.
* Have good venous access.
* Must be able to swallow tablets and pills

Exclusion Criteria

* Pregnant, trying to become pregnant, or breast feeding.
* Chronic or acute use of prescription or OTC medications that may interfere with absorption of the test supplement.
* Consumption of a multivitamin/mineral or other dietary supplement for more than 5 days within 30 days of the screening visit.
* Gastrointestinal conditions that may affect consumption of the treatment or placebo tablets.
* insulin-dependent and orally controlled diabetics
* Scheduling difficulties or lack of transportation
* Have participated as a subject in any other clinical study within 30 days of the screening visit
* A history of alcohol or substance abuse within 2 years
* Significant constipation or diarrhea
* Allergies or intolerance to turmeric, curcumin or related products
* Inability or difficulty swallowing tablets and pills
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USANA Health Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Levy, PhD

Role: PRINCIPAL_INVESTIGATOR

USANA Health Sciences

Locations

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USANA Health Sciences

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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201773

Identifier Type: -

Identifier Source: org_study_id