Effect of a MVM Dietary Supplement on Indices of Human Health

USANA Health Sciences

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: MVM/phytochemical supplement

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03488992

16MHHU

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts 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