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

Study Overview
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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: Daily consumption of the control supplement (placebo) 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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: MVM/phytochemical supplement
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MVM/phytochemical supplement<br>a multi-vitamin, multi-mineral, phytochemical supplement | Dietary Supplement: MVM/phytochemical supplement<br>* Consumption of an MVM/phytochemical supplement for 4 weeks<br>|
| Placebo Comparator: Placebo<br>a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment | Dietary Supplement: Placebo<br>* Consumption of a placebo tablet identical in size, shape and color to the treatment tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression | Gene expression measured by microarray | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | change in inflammatory markers between MVM/Phytochemical Supplement and placebo | 4 weeks | 
| Cardiovascular Health | change in markers of cardiovascular health between MVM/Phytochemical Supplement and placebo | 4 weeks | 
| Nutritional status | change in markers of nutritional status between MVM/Phytochemical Supplement and placebo | 4 weeks | 
| Oxidative stress/Antioxidant Status | change in oxidative stress markers between MVM/Phytochemical Supplement and placebo | 4 weeks | 
| Epigenetics | Changes in DNA methylation patterns | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gene expression, gene array, epigenetics, DNA methylation