Effect of a MVM Dietary Supplement on Indices of Human Health

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.

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