Standard Process Heart and Gut Health Study
This prospective pilot clinical study will screen 45 healthy participants regularly consuming omnivorous diet (full fat dairy, red meat, eggs, fish) and have elevated serum Trimethyl amine N-oxide (TMAO) levels. Trimethylamine N-oxide (TMAO) is a gut microbiota derived dietary metabolite which is emerging as a significant and independent predictor of cardiovascular disease (CVD) risk mainly through inflammation and oxidative stress pathways. Long term consumption of animal products elevates TMAO levels due to its abundance of TMAO precursors: choline and L-carnitine. As diet plays a key role in altering the microbial composition and subsequent TMAO levels, it is important to investigate if whole food based nutritional formulations can provide the necessary support required to manage TMAO levels and hence, positively impact cardiometabolic endpoints. Towards this end both B and D vitamins have been shown to influence the levels of circulating TMAO while maintaining a healthy gut microenvironment. This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
14
Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, United States
Primary
One outcome is to determine if a combination of whole food-based B-vitamins can modulate gut diversity and TMAO response
Time frame: 8 weeks
Secondary
Another outcome is to explore the beneficial interplay between B and D vitamin supplementation in reducing TMAO levels through modulation of gut microbiome.
Time frame: 8 weeks
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