Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 5:04 AM
Study NCT ID:
NCT06758869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in substrate oxidation in response to eating differentially processed pulse-based food products', 'timeFrame': '12 weels', 'description': '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.'}, {'measure': 'Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks', 'timeFrame': '12 weeks', 'description': 'Measure changes in fat, carbohydrate, and protein oxidation in response to consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta using whole room calorimetry'}, {'measure': 'Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.', 'timeFrame': '12 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/', 'label': 'Grand Forks Human Nutrition Research Center Current Nutrition Studies'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* apparently healthy adults\n* BMI \\>18.5 or \\<35 kg/m2 (healthy body weight - class I obesity)\n* ability to understand and sign the consent form\n* availability of transportation (i.e., participants must provide their own transportation to the Center)\n* non-smoking or do not use other tobacco products, including e-cigarettes\n* not taking steroid-based medications\n* not planning to or currently attempting to gain or lose weight\n* not allergic to study foods\n* willing to comply with study demands\n\nExclusion Criteria:\n\n* usual pulse consumption greater than DGA recommendation\n* inability or unwillingness to consume any of the provided foods\n* more than a 10% change in body weight within the past 2 months\n* actively trying to lose weight\n* pregnancy or actively trying to get pregnant\n* lactation\n* uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg)\n* diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases\n* HbA1c ≥ 5.7%\n* complete blood count (CBC) outside of the normal range for a healthy adult\n* 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)\n* using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)\n* cannot read or understand English"}, 'identificationModule': {'nctId': 'NCT06758869', 'briefTitle': 'Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health', 'orgStudyIdInfo': {'id': 'GFHNRC514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Base DGA diet with a standardized non-pulse product snack', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Whole Chickpeas', 'description': 'Adjusted DGA diet with standardized whole chickpea snack', 'interventionNames': ['Other: Whole Chickpeas']}, {'type': 'EXPERIMENTAL', 'label': 'Puréed Chickpeas', 'description': 'Adjusted DGA diet with standardized puréed chickpea snack', 'interventionNames': ['Other: Puréed Chickpeas']}, {'type': 'EXPERIMENTAL', 'label': '100% Chickpea Flour Product', 'description': 'Adjusted DGA diet with standardized 100% chickpea flour product snack', 'interventionNames': ['Other: 100% Chickpea Flour Product']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Participants will consume the Base DGA diet with a standardized non-pulse product snack.', 'armGroupLabels': ['Control']}, {'name': 'Whole Chickpeas', 'type': 'OTHER', 'description': 'Participants will consume an adjusted DGA diet with a standardized whole chickpea snack.', 'armGroupLabels': ['Whole Chickpeas']}, {'name': 'Puréed Chickpeas', 'type': 'OTHER', 'description': 'Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack.', 'armGroupLabels': ['Puréed Chickpeas']}, {'name': '100% Chickpea Flour Product', 'type': 'OTHER', 'description': 'Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.', 'armGroupLabels': ['100% Chickpea Flour Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58203', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'contacts': [{'name': 'Angela Scheett', 'role': 'CONTACT', 'email': 'angela.scheett@usda.gov', 'phone': '701-795-8386'}], 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'centralContacts': [{'name': 'Shanon Casperson, PhD', 'role': 'CONTACT', 'email': 'shanon.casperson@usda.gov', 'phone': '701-795-8497'}], 'overallOfficials': [{'name': 'Shanon Casperson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Biologist', 'investigatorFullName': 'Shanon Casperson', 'investigatorAffiliation': 'USDA Grand Forks Human Nutrition Research Center'}}}}