NCT03488992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

March 2, 2017

Last Update Submit

March 28, 2018

Conditions

Metabolic Syndrome

Keywords

dietary supplement, cardiovascular health, oxidative stress

Outcome Measures

Primary Outcomes (1)

  • HDL Cholesterol

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

    8 weeks

Secondary Outcomes (7)

  • Inflammation

    8 weeks

  • Oxidative Stress

    8 weeks

  • Cardiovascular Health

    8 weeks

  • Nutritional status

    8 weeks

  • Neurological Health

    8 weeks

  • +2 more secondary outcomes

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 supplementDIETARY_SUPPLEMENT

Consumption of an MVM/phytochemical supplement for 8 weeks

MVM/phytochemical supplement
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mark Levy

    USANA Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2017

First Posted

April 5, 2018

Study Start

January 10, 2017

Primary Completion

February 25, 2018

Study Completion

February 25, 2018

Last Updated

April 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)