Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVM/phytochemical supplement | Experimental | a multi-vitamin, multi-mineral, phytochemical supplement |
|
| Placebo | Placebo Comparator | a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVM/phytochemical supplement | Dietary Supplement | Consumption of an MVM/phytochemical supplement for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression | Gene expression measured by microarray | 4 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Levy, PhD | USANA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USANA Health Sciences | Salt Lake City | Utah | 84120 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Consumption of a placebo tablet identical in size, shape and color to the treatment tablet |
|
| 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 |