Pulse Biomarker Discovery

Body Weight Clinical Trial

Official title: Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors

Status Completed

Clinical Trial Summary

Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and minerals. Moderate pulse consumption is associated with improvements in glycemic control and reduced risk of cardiovascular disease, obesity and type 2 diabetes. Measuring pulse consumption in humans is difficult, due to limitations in current methods for dietary assessment which are largely based on dietary recalls that are subject to reporting bias. Robust tools for pulse intake assessment are needed, and biomarkers of dietary pulse intake are one approach to solve this problem. The goal of this human feeding study is evaluate the presence of biomarkers of dietary pulses in human subjects.

Clinical Trial Description

Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and minerals. Moderate pulse consumption is associated with improvements in glycemic control and reduced risk of cardiovascular disease, obesity and type 2 diabetes. However, only 5% of the U.S. population currently meet recommended fiber intakes. As pulses are an excellent source of fiber, increasing their levels in the American diet could lead to demonstrable health benefits in the population, including positive influences on glucose regulation. Additionally, pulse impacts on the gut microbiome may be responsible for reported health benefits. While diet has direct impacts on health, these effects can be mediated by the microbiome, and dietary fiber is a key determinant of this interaction. The fermentation of soluble fiber by specific microbial species lead to the production of short chain fatty acids (SCFAs) including propionate and butyrate which are positively associated with insulin sensitivity. In general, elevated colonic SCFA production is associated with improved glucose regulation, appetite modulation, and immune system modulation.

The overall goal of this research is to evaluate how pulse digestion and microbial fermentation influence the circulating and excreted metabolome. To achieve this goal, a randomized controlled feeding study including one week of control, low pulse and high pulse diet will be provided to participants. Metabolomics will be used to identify biomarkers or signatures for pulse enriched diets in urine and plasma. In addition, researchers will investigate dietary pulse related changes in the microbiome community and short chain fatty acid production in fecal samples. ;

Related Conditions & MeSH terms

• Body Weight

• NCT number: NCT04887584
• Study type: Interventional
• Source: USDA, Western Human Nutrition Research Center
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Completion date: November 7, 2023