NCT05795946

Standard Process Heart and Gut Health Study

Effects of a Whole Food Based Nutritional Formulation on Trimethylamine N-oxide and Cardiometabolic Endpoints in Healthy Adults.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Standard Process Inc. · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Standard Process Heart and Gut Health Study

Detailed description

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.

Conditions

• Nutrition, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whole food-based B and D vitamins	Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-04-03
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States