Pulse Biomarker Discovery
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Control diet; Low Pulse diet; High Pulse diet
Intervention type(s): Other; Other; Other
Intervention description(s): The control Typical American Diet (TAD) diet pattern will mimic the level of intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium in the general U.S. population. This diet will feature no servings of pulses per day.; The Low Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 0.2 cups of pulses per day at 2,000 kilocalories (kcals).; The High Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 1.5 cups of pulses per day at 2,000 kilocalories (kcals).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dietary pulses; Urine biomarkers; Microbiome; Short chain fatty acids; Plasma biomarkers; Fecal biomarkers; Beans; Lentils; Controlled feeding; Intervention; Chickpeas; Metabolomics