NCT03488992

Effect of a MVM Dietary Supplement on Indices of Human Health

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: USANA Health Sciences · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MVM/phytochemical supplement	Consumption of an MVM/phytochemical supplement for 8 weeks
DIETARY_SUPPLEMENT	Placebo	Consumption of a placebo tablet identical in size, shape and color to the treatment tablet

Timeline

• Start date: 2017-01-10
• Primary completion: 2018-02-25
• Completion: 2018-02-25
• First posted: 2018-04-05
• Last updated: 2018-04-05

Locations

1 site across 1 country: Canada