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

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.

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