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Pulse Biomarker Discovery

Primary Purpose

Body Weight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control diet
Low Pulse diet
High Pulse diet
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Weight focused on measuring Dietary pulses, Urine biomarkers, Microbiome, Short chain fatty acids, Plasma biomarkers, Fecal biomarkers, Beans, Lentils, Controlled feeding, Intervention, Chickpeas, Metabolomics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USDA ARS Western Human Nutrition Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Arm Description

Order of treatments: A: Control diet B: Low pulse diet C: High pulse diet

Order of treatments: A: Control diet C: High pulse diet B: Low pulse diet

Order of treatments: B: Low pulse diet A: Control diet C: High pulse diet

Order of treatments: B: Low pulse diet C: High pulse diet A: Control diet

Order of treatments: C: High pulse diet A: Control diet B: Low pulse diet

Order of treatments: C: High pulse diet B: Low pulse diet A: Control diet

Outcomes

Primary Outcome Measures

Change in urine metabolomics profile
Urine metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.
Change in plasma metabolomics profile
Plasma metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.

Secondary Outcome Measures

Change in fecal microbiome community
DNA of colonic microbiome will be measured before and after each diet exposure.
Change in fecal short chain fatty acids
Acetate, propionate and butyrate will be measured by GCMS before and after each diet exposure.
Change in fecal bile acids
Bile acids will be measured by GCMS before and after each diet exposure.
Change in plasma short-chain fatty acids
Plasma acetate, propionate and butyrate will be measured by GCMS before and after consumption of control, low pulse or high pulse diets.
Change in pro-inflammatory cytokines
Cytokines including tumor necrosis factor alpha (TNF-a), interleukin (IL)-1, IL-6 and interferon-gamma will be measured in plasma using multiplex assays.
Change in anti-inflammatory cytokines
Cytokines including interleukin (IL)-1 receptor antagonist, IL-4, IL-10, IL-11, and IL-13 will be measured in plasma using multiplex assays.

Full Information

First Posted
May 10, 2021
Last Updated
October 23, 2023
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04887584
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
Dietary pulses, Urine biomarkers, Microbiome, Short chain fatty acids, Plasma biomarkers, Fecal biomarkers, Beans, Lentils, Controlled feeding, Intervention, Chickpeas, Metabolomics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Unblinded
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Order of treatments: A: Control diet B: Low pulse diet C: High pulse diet
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Order of treatments: A: Control diet C: High pulse diet B: Low pulse diet
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Order of treatments: B: Low pulse diet A: Control diet C: High pulse diet
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Order of treatments: B: Low pulse diet C: High pulse diet A: Control diet
Arm Title
Group 5
Arm Type
Experimental
Arm Description
Order of treatments: C: High pulse diet A: Control diet B: Low pulse diet
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Order of treatments: C: High pulse diet B: Low pulse diet A: Control diet
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low Pulse diet
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
High Pulse diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in urine metabolomics profile
Description
Urine metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.
Time Frame
Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr
Title
Change in plasma metabolomics profile
Description
Plasma metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.
Time Frame
Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary Outcome Measure Information:
Title
Change in fecal microbiome community
Description
DNA of colonic microbiome will be measured before and after each diet exposure.
Time Frame
Day 7, 14, 21, 28, 35, 42
Title
Change in fecal short chain fatty acids
Description
Acetate, propionate and butyrate will be measured by GCMS before and after each diet exposure.
Time Frame
Day 7, 14, 21, 28, 35, 42
Title
Change in fecal bile acids
Description
Bile acids will be measured by GCMS before and after each diet exposure.
Time Frame
Day 7, 14, 21, 28, 35, 42
Title
Change in plasma short-chain fatty acids
Description
Plasma acetate, propionate and butyrate will be measured by GCMS before and after consumption of control, low pulse or high pulse diets.
Time Frame
Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Title
Change in pro-inflammatory cytokines
Description
Cytokines including tumor necrosis factor alpha (TNF-a), interleukin (IL)-1, IL-6 and interferon-gamma will be measured in plasma using multiplex assays.
Time Frame
Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Title
Change in anti-inflammatory cytokines
Description
Cytokines including interleukin (IL)-1 receptor antagonist, IL-4, IL-10, IL-11, and IL-13 will be measured in plasma using multiplex assays.
Time Frame
Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen L Bonnel, PhD
Phone
530-752-4184
Email
ellen.bonnel@usda.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Bennett, PhD
Organizational Affiliation
USDA ARS Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA ARS Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Bonnel, PhD
Phone
530-752-4184
Email
ellen.bonnel@usda.gov
First Name & Middle Initial & Last Name & Degree
John W Newman, PhD
First Name & Middle Initial & Last Name & Degree
Francene M Steinberg, PhD
First Name & Middle Initial & Last Name & Degree
Brian J Bennett, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Pulse Biomarker Discovery

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