Clinical trial NCT03488992: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: dietary supplement, cardiovascular health, oxidative stress
Lead sponsor: USANA Health Sciences
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2018-04-05
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: HDL Cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Inflammation
timeFrame: 8 weeks
measure: Oxidative Stress
timeFrame: 8 weeks
measure: Cardiovascular Health
timeFrame: 8 weeks
measure: Nutritional status
timeFrame: 8 weeks
measure: Neurological Health
timeFrame: 8 weeks
measure: Microbiome
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize
state: Ontario
Study officials:
affiliation: USANA Health Sciences
name: Mark Levy
role: PRINCIPAL_INVESTIGATOR
References: