Status:
COMPLETED
Pulse Biomarker Discovery
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Collaborating Sponsors:
University of California, Davis
Conditions:
Body Weight
Eligibility:
All Genders
18-65 years
Phase:
NA
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 pro...
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 pro...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) 18-30 kg/m2
- Willingness to provide urine and stool and have blood drawn
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04887584
Start Date
May 1 2022
End Date
November 7 2023
Last Update
October 26 2024
Active Locations (1)
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1
USDA ARS Western Human Nutrition Research Center
Davis, California, United States, 95616