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Effect of a MVM Dietary Supplement on Indices of Human Health

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

MVM/phytochemical supplement

Placebo

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring dietary supplement, cardiovascular health, oxidative stress

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

KGK Synergize

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MVM/phytochemical supplement

Placebo

Arm Description

a multi-vitamin, multi-mineral, phytochemical supplement

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

Outcomes

Primary Outcome Measures

HDL Cholesterol

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

Secondary Outcome Measures

Inflammation

change in inflammatory markers between MVM/Phytochemical Supplement and placebo including circulating levels of IL-1b, TNF-a, and IFNg

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)

Cardiovascular Health

change in markers of cardiovascular health between MVM/Phytochemical including Cholesterol levels Supplement and placebo (LDL, HDL, total cholesterol, homocysteine)

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)

Neurological Health

change in markers of neurological health between MVM/Phytochemical Supplement and placebo

Microbiome

change in microbiome between MVM/Phytochemical Supplement and placebo using 16s analysis

Quality of Life

difference in self-perceived quality of life between MVM/Phytochemical Supplement and placebo using the SF-36 questionnaire

Full Information

NCT ID

NCT03488992

First Posted

March 2, 2017

Last Updated

March 28, 2018

Sponsor

USANA Health Sciences

Collaborators

KGK Science Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03488992

Brief Title

Effect of a MVM Dietary Supplement on Indices of Human Health

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 10, 2017 (Actual)

Primary Completion Date

February 25, 2018 (Actual)

Study Completion Date

February 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

USANA Health Sciences

Collaborators

KGK Science Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

dietary supplement, cardiovascular health, oxidative stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MVM/phytochemical supplement

Arm Type

Experimental

Arm Description

a multi-vitamin, multi-mineral, phytochemical supplement

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

MVM/phytochemical supplement

Intervention Description

Consumption of an MVM/phytochemical supplement for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

HDL Cholesterol

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Inflammation

Description

change in inflammatory markers between MVM/Phytochemical Supplement and placebo including circulating levels of IL-1b, TNF-a, and IFNg

Time Frame

8 weeks

Title

Oxidative Stress

Description

Time Frame

8 weeks

Title

Cardiovascular Health

Description

change in markers of cardiovascular health between MVM/Phytochemical including Cholesterol levels Supplement and placebo (LDL, HDL, total cholesterol, homocysteine)

Time Frame

8 weeks

Title

Nutritional status

Description

change in markers of nutritional status between MVM/Phytochemical Supplement and placebo including vitamins A,D,E,K,C,B6,B12 and folate)

Time Frame

8 weeks

Title

Neurological Health

Description

change in markers of neurological health between MVM/Phytochemical Supplement and placebo

Time Frame

8 weeks

Title

Microbiome

Description

change in microbiome between MVM/Phytochemical Supplement and placebo using 16s analysis

Time Frame

8 weeks

Title

Quality of Life

Description

difference in self-perceived quality of life between MVM/Phytochemical Supplement and placebo using the SF-36 questionnaire

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Levy

Organizational Affiliation

USANA Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

KGK Synergize

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5R8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Effect of a MVM Dietary Supplement on Indices of Human Health

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