Healthy
Conditions
Keywords
gene expression, gene array, epigenetics, DNA methylation
Brief 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.
Interventions
DIETARY_SUPPLEMENTMVM/phytochemical supplement
Consumption of an MVM/phytochemical supplement for 4 weeks
DIETARY_SUPPLEMENTPlacebo
Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
Sponsors
USANA Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | 4 weeks | Gene expression measured by microarray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 4 weeks | change in inflammatory markers between MVM/Phytochemical Supplement and placebo |
| Cardiovascular Health | 4 weeks | change in markers of cardiovascular health between MVM/Phytochemical Supplement and placebo |
| Nutritional status | 4 weeks | change in markers of nutritional status between MVM/Phytochemical Supplement and placebo |
| Oxidative stress/Antioxidant Status | 4 weeks | change in oxidative stress markers between MVM/Phytochemical Supplement and placebo |
| Epigenetics | 4 weeks | Changes in DNA methylation patterns |
Countries
United States
Outcome results
None listed