Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health

Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Gene Expression, Epigenetics and Nutritional Status in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: MVM/phytochemical supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84120
      • USANA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MVM/phytochemical supplement; a multi-vitamin, multi-mineral, phytochemical supplement	Dietary supplement: MVM/phytochemical supplement; Consumption of an MVM/phytochemical supplement for 4 weeks
PLACEBO_COMPARATOR: Placebo; a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment	Dietary supplement: Placebo; Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression	Gene expression measured by microarray	4 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: USANA Health Sciences
• Investigators: Principal Investigator: Mark Levy, PhD, USANA Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ACTUAL): June 8, 2017
• Study Completion (ACTUAL): June 8, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: DNA methylation; gene expression; epigenetics; gene array
• Other Study ID Numbers: 201773 (IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No