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

NCT03146312 | Completed

• 1 other identifier: 201773
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

gene expression; gene array; epigenetics; DNA methylation

Outcome Measures

Primary Outcomes (1)

• Gene expression

  Gene expression measured by microarray

  4 weeks

Secondary Outcomes (5)

• Inflammation

  4 weeks

• Cardiovascular Health

  4 weeks

• Nutritional status

  4 weeks

• Oxidative stress/Antioxidant Status

  4 weeks

• Epigenetics

  4 weeks

Study Arms (2)

MVM/phytochemical supplement

EXPERIMENTAL

a multi-vitamin, multi-mineral, phytochemical supplement

Dietary Supplement: MVM/phytochemical supplement

Placebo

PLACEBO COMPARATOR

a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment

Dietary Supplement: Placebo

Interventions

MVM/phytochemical supplement DIETARY_SUPPLEMENT

Consumption of an MVM/phytochemical supplement for 4 weeks

MVM/phytochemical supplement

Placebo DIETARY_SUPPLEMENT

Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USANA Health Sciences: lead

Study Sites (1)

USANA Health Sciences

Salt Lake City, Utah, 84120, United States

Location

Study Officials

• Mark Levy, PhD

  USANA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: April 20, 2017
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

US (1)