Clinical trial NCT04887584: Pulse Biomarker Discovery
Official title: Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Keywords: Dietary pulses
Urine biomarkers
Microbiome
Short chain fatty acids
Plasma biomarkers
Fecal biomarkers
Beans
Lentils
Controlled feeding
Intervention
Chickpeas
Metabolomics
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: University of California, Davis
First posted: 2021-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) 18-30 kg/m2
* Willingness to provide urine and stool and have blood drawn

Exclusion Criteria:

* Active participation in another research study
* Tested positive for severe acute respiratory syndrome (SARS) Coronavirus (COV)-2 within the past 10 days
* Been in close contact with a SARS COV-2 positive person within the past 14 days
* Unwillingness to consume pulses or pulse-related products
* Fasting glucose ≥120 mg/dL
* Fasting triglyceride ≥400 mg/dL
* LDL-cholesterol ≥160 mg/dL
* Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg
* Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements

  * Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities)
  * Unwillingness to consume intervention foods and beverages
  * Engage in

    * More than moderate drinking (\> 1 drink serving per day for women or \>2 drink servings per day for men).
    * Binge drinking (4 drinks within two hours).
  * Excessive intake of caffeine containing products (excessive defined as ≥ 400mg/day)
  * Diagnosis of disordered eating or eating disorder
  * Recent diagnosis of any of the following or measurement on screening lab tests

    * Anemia (hemoglobin \<11.7g/dL)
    * Abnormal liver function
    * Liver Enzymes that are \>200% of upper limit (alanine aminotransferase (ALT) upper limit is 43 U/L or aspartate aminotransferase (AST) upper limit is 54 U/L)
  * History of any of the following

    * Gastric bypass surgery
    * Inflammatory bowel disease (IBD) or other GI conditions that would interfere with consuming the intervention foods
    * Active cancer in the past three years excluding squamous or basal cell carcinomas of the skin that have been handled medically by local excision
    * Other serious medical conditions
  * Recent dental work or have conditions of the oral cavity that would interfere with consuming the intervention foods and beverages
  * Long term use of antibiotics
  * Taking any over the counter or prescribed medication for any of the following

    * Elevated lipids or glucose
    * High blood pressure
    * Weight loss
  * Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.

Primary outcomes:
measure: Change in urine metabolomics profile
timeFrame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr
measure: Change in plasma metabolomics profile
timeFrame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary outcomes:
measure: Change in fecal microbiome community
timeFrame: Day 7, 14, 21, 28, 35, 42
measure: Change in fecal short chain fatty acids
timeFrame: Day 7, 14, 21, 28, 35, 42
measure: Change in fecal bile acids
timeFrame: Day 7, 14, 21, 28, 35, 42
measure: Change in plasma short-chain fatty acids
timeFrame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
measure: Change in pro-inflammatory cytokines
timeFrame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
measure: Change in anti-inflammatory cytokines
timeFrame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA ARS Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA ARS Western Human Nutrition Research Center
name: Brian J Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
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