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

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.

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