Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas
Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Shanon Casperson, PhD
- Phone Number: 701-795-8497
- Email: shanon.casperson@usda.gov
Study Locations
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North Dakota
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Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
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Contact:
- Angela Scheett
- Phone Number: 701-795-8386
- Email: angela.scheett@usda.gov
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- apparently healthy adults
- BMI >18.5 or <35 kg/m2 (healthy body weight - class I obesity)
- ability to understand and sign the consent form
- availability of transportation (i.e., participants must provide their own transportation to the Center)
- non-smoking or do not use other tobacco products, including e-cigarettes
- not taking steroid-based medications
- not planning to or currently attempting to gain or lose weight
- not allergic to study foods
- willing to comply with study demands
Exclusion Criteria:
- usual pulse consumption greater than DGA recommendation
- inability or unwillingness to consume any of the provided foods
- more than a 10% change in body weight within the past 2 months
- actively trying to lose weight
- pregnancy or actively trying to get pregnant
- lactation
- uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
- HbA1c ≥ 5.7%
- complete blood count (CBC) outside of the normal range for a healthy adult
- history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
- using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
- cannot read or understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Control
Base DGA diet with a standardized non-pulse product snack
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Participants will consume the Base DGA diet with a standardized non-pulse product snack.
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Experimental: Whole Chickpeas
Adjusted DGA diet with standardized whole chickpea snack
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Participants will consume an adjusted DGA diet with a standardized whole chickpea snack.
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Experimental: Puréed Chickpeas
Adjusted DGA diet with standardized puréed chickpea snack
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Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack.
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Experimental: 100% Chickpea Flour Product
Adjusted DGA diet with standardized 100% chickpea flour product snack
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Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in substrate oxidation in response to eating differentially processed pulse-based food products
Time Frame: 12 weels
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Using whole-room calorimetry, measure differences in fat, carbohydrate, and protein oxidation in response to daily consumption of whole chickpeas, pureed chickpeas, or chickpea-flour pasta compared to a control diet.
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12 weels
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Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks
Time Frame: 12 weeks
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Measure changes in fat, carbohydrate, and protein oxidation in response to consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta using whole room calorimetry
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12 weeks
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Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire
Time Frame: Baseline
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The questionnaire is designed to assess enjoyment (two items), sensory properties (eight items), perceived cooking abilities (ten items), perceived practical aspects (six items), perceived healthiness (two items), upbringing (two items), social influences (four items), and quality issues (six items) of pulse consumption.
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Baseline
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products
Time Frame: 12 weeks
|
Fecal samples will be collected at Baseline and then again at weeks 4, 8, and 12 to identify how the predominant colon bacteria phyla are effected by consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta for 12 weeks.
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12 weeks
|
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Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.
Time Frame: 12 weeks
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Blood samples will be collected before and after consuming whole chickpeas, pureed chickpeas, or chickpeas-flour pasta for 12 weeks to identify how consuming these foods effect the expression genes involved with fat metabolism.
This will be accomplished by combining the different snapshots provided from pre/post intervention metabolomic, transcriptomic, and proteomic analysis.
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12 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- GFHNRC514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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