Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
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About
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.
Full 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:
- 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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