Effect of a MVM Dietary Supplement on Indices of Human Health

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

The purpose of this study is to investigate the health benefits of a recently developed multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This newly developed supplement - an advancement of a previous formula designed to enhance human health by providing RDA-levels of essential vitamins and minerals - contains eight phytochemicals selected to address fruit and vegetable undernutrition, and chosen on the basis that: 1) published research from cell culture, animal model and, when available, human clinical work, suggests that it may benefit human health, and 2) it is considered safe for human ingestion at proposed levels of consumption.

Study Overview

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

Detailed Description

This study will be an eight-week, randomized, placebo controlled, parallel arm clinical trial to compare markers of nutritional, inflammatory and oxidative status, cardiovascular and neurological health as well as microbial status in subjects consuming a novel multivitamin/multimineral/phytochemical (MVM/phytochemical) supplement compared to subjects consuming a placebo tablet. In addition, this study will evaluate whether the MVM/phytochemical supplement improves subjects sense of well-being as evaluated by a quality-of-life survey. The study will aim to enroll 112 consenting men and women characterized as having metabolic syndrome. Potential subjects will be recruited through flyers, newspapers and advertisements placed throughout the community. Consented subjects will undergo a 28-day washout, followed by a 56-day trial period. Biological samples (blood, urine, stool, saliva) will be collected at baseline (day 0) and at day 56. Diet and exercise history, as well as a quality of life survey, will be collected at these time points as well. Risk to participants is expected to be minimal and will be outlined through an informed consent.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body Mass Index of 29.9 to 40 kg/m2 ±1 kg/m2
• Waist measurement for males ≥ 102 cm (40 inches) or for females ≥ 89 cm (35 inches)

• two or more of the following risk factors:

  • Elevated blood pressure ( 130/85 mm Hg)
  • Fasting elevated triglycerides > 1.69 mmol/L ( 150 mg/dL)
  • Elevated fasting glucose > 5.56 mmol/L ( 100 mg/dL) and <7.0 mmol/L (<126 mg/dL)
  • Low HDL cholesterol <1.29 mmol/L ( 50 mg/dL) for females, and <1.03 mmol/L ( 40 mg/dL) for males
• Not currently taking a multivitamin/mineral, antioxidant supplement, or other dietary supplements or are willing to wash out for 4 weeks before enrollment

Exclusion Criteria:

• Pregnant and/ or lactating females or females trying to become pregnant
• Use of lipid lowering medications
• Lipid lowering OTC or herbal supplements within 3 weeks of enrollment
• Use of conventional multivitamin/mineral, antioxidant supplements or other dietary supplements within four weeks prior to enrollment
• Insulin-dependent Type I and Type II diabetics
• Diabetic men > 45 years and diabetic women > 55 years
• Metformin or other diabetes medications are prohibited in this study
• Type II diabetes controlled by diet and/or exercise
• Elevated blood pressure ( 160/95 mm Hg) at screening
• Individuals with a history of coronary artery disease, previous myocardial infarction, peripheral vascular disease, or atherosclerosis
• Men above 50 years and women above 60 years who have a 10-year risk of cardiovascular event FRS between 10% and 19% (inclusive) at screening and who present with one of the following LDL-C > 3.5 mmol/L, TC/HDL-C ratio > 5.0, or hs-CRP > 2 mg/L
• Individuals with a 10-year risk of cardiovascular event FRS < 10% at screening and present with LDL-C > 5.0 mmol/L or TC/HDL-C ratio > 6.0
• Participants taking blood thinners
• Participants with stomach ulcers, gall stones, or bile duct obstruction

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 8 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
HDL Cholesterol	Effect of MVM/Phytochemical Supplement on HDL-cholesterol levels compared to placebo	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	change in inflammatory markers between MVM/Phytochemical Supplement and placebo including circulating levels of IL-1b, TNF-a, and IFNg	8 weeks
Oxidative Stress	change in oxidative stress markers between MVM/Phytochemical Supplement and placebo including antioxidant enzyme activity (SOD, Catalase, GSH-Px) and markers of oxidative stress (GSH/GSSG, 8-isoprostanes)	8 weeks
Cardiovascular Health	change in markers of cardiovascular health between MVM/Phytochemical including Cholesterol levels Supplement and placebo (LDL, HDL, total cholesterol, homocysteine)	8 weeks
Nutritional status	change in markers of nutritional status between MVM/Phytochemical Supplement and placebo including vitamins A,D,E,K,C,B6,B12 and folate)	8 weeks
Neurological Health	change in markers of neurological health between MVM/Phytochemical Supplement and placebo	8 weeks
Microbiome	change in microbiome between MVM/Phytochemical Supplement and placebo using 16s analysis	8 weeks
Quality of Life	difference in self-perceived quality of life between MVM/Phytochemical Supplement and placebo using the SF-36 questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: USANA Health Sciences
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: Mark Levy, USANA Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2017
• Primary Completion (ACTUAL): February 25, 2018
• Study Completion (ACTUAL): February 25, 2018

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: dietary supplement, cardiovascular health, oxidative stress
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 16MHHU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO