NCT03146312

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

Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Gene Expression, Epigenetics and Nutritional Status in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: USANA Health Sciences · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MVM/phytochemical supplement	Consumption of an MVM/phytochemical supplement for 4 weeks
DIETARY_SUPPLEMENT	Placebo	Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

Timeline

• Start date: 2017-04-20
• Primary completion: 2017-06-08
• Completion: 2017-06-08
• First posted: 2017-05-09
• Last updated: 2018-03-30

Locations

1 site across 1 country: United States