General Nutritional Status Clinical Trial
Official title:
Effects of Multivitamin, Multimineral and Phytonutrient Supplementation on Selected Nutrients Blood Level and Heart Health Risk Factors in Russian Population
The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin multimineral with phytonutrient product vs. placebo on heart health risk factors following twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the multivitamin multimineral with phytonutrient product vs. placebo following twice-daily consumption for eight weeks.
More and more evidence shows the benefit of fruit and vegetable intake on the maintenance of good health throughout the lift span. Unfortunately, many people in developed and developing societies do not eat a diet with the variety and quantity of fruits and vegetables. Because of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden on the health care system. Therefore, promoting healthy lifestyle and dietary behavior becomes a critical approach in preventing chronic disease development. According to results from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the World Health Organization's recommended 400 grams per day. This lower than recommended intake would correlate to a lower intake of phytonutrients and antioxidants and may be associated with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In this study, we are particularly interested in understanding whether a multivitamin multimineral with phytonutrient product can improve nutritional status and reduce heart health risk factors in Russian population with low fruit and vegetable intake. This study is conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients department. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention