Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
- Conditions
- Healthy
- Interventions
- Dietary Supplement: MVM/phytochemical supplementDietary Supplement: Placebo
- Registration Number
- NCT03146312
- Lead Sponsor
- USANA Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MVM/phytochemical supplement MVM/phytochemical supplement a multi-vitamin, multi-mineral, phytochemical supplement Placebo Placebo a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment
- Primary Outcome Measures
Name Time Method Gene expression 4 weeks Gene expression measured by microarray
- Secondary Outcome Measures
Name Time Method 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
Inflammation 4 weeks change in inflammatory markers between MVM/Phytochemical Supplement and placebo
Trial Locations
- Locations (1)
USANA Health Sciences
🇺🇸Salt Lake City, Utah, United States