Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): MVM/phytochemical supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of an MVM/phytochemical supplement for 4 weeks; Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gene expression; gene array; epigenetics; DNA methylation