- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758869
Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas
April 22, 2026 updated by: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health
The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food.
For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The overall objective is to determine the impact of daily consumption of processed pulse-based food products on metabolic health, specifically the physiological responses related to energy metabolism.
The primary hypothesis is that consuming a serving of pulses daily for 12 weeks will improve metabolic responses related to energy metabolism, particularly fat oxidation and molecular adaptations related to fat and glucose metabolism, compared to current Dietary Guidelines for Americans (DGA) recommendations.
Furthermore, we hypothesize that the degree of processing will influence these metabolic adaptations such that the daily consumption of 100% pulse flour food products will result in the greatest effect on fat oxidation and molecular adaptations related to fat and glucose metabolism followed by the pulse purée which will have a greater effect than the whole cooked pulse (100% pulse flour > purée > whole).
Study Type
Interventional
Enrollment (Estimated)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shanon Casperson, PhD
- Phone Number: 701-795-8497
- Email: shanon.casperson@usda.gov
Study Locations
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
-
Contact:
- Angela Scheett
- Phone Number: 701-795-8386
- Email: angela.scheett@usda.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
Base DGA diet with a standardized non-pulse product snack
|
Participants will consume the Base DGA diet with a standardized non-pulse product snack.
|
|
Experimental: Whole Chickpeas
Adjusted DGA diet with standardized whole chickpea snack
|
Participants will consume an adjusted DGA diet with a standardized whole chickpea snack.
|
|
Experimental: Puréed Chickpeas
Adjusted DGA diet with standardized puréed chickpea snack
|
Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack.
|
|
Experimental: 100% Chickpea Flour Product
Adjusted DGA diet with standardized 100% chickpea flour product snack
|
Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.
|
What is the study measuring?
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
|
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.
|
12 weels
|
|
Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks
Time Frame: 12 weeks
|
Measure changes in fat, carbohydrate, and protein oxidation in response to consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta using whole room calorimetry
|
12 weeks
|
|
Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire
Time Frame: Baseline
|
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.
|
Baseline
|
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.
|
12 weeks
|
|
Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
December 19, 2024
First Submitted That Met QC Criteria
January 2, 2025
First Posted (Actual)
January 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- GFHNRC514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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