Clinical trial NCT03146312: Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
Official title: Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Gene Expression, Epigenetics and Nutritional Status in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: gene expression
gene array
epigenetics
DNA methylation
Lead sponsor: USANA Health Sciences
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gene expression
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammation
timeFrame: 4 weeks
measure: Cardiovascular Health
timeFrame: 4 weeks
measure: Nutritional status
timeFrame: 4 weeks
measure: Oxidative stress/Antioxidant Status
timeFrame: 4 weeks
measure: Epigenetics
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: USANA Health Sciences
state: Utah
Study officials:
affiliation: USANA Health Sciences
name: Mark Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References: