Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:17 AM
Study NCT ID:
NCT07489118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078724', 'term': 'Pea Proteins'}], 'ancestors': [{'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune activation of PMBC cells', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Global PMBC transcriptome analysis (DGE RNA-Seq)'}, {'measure': 'Gastrointestinal microbiome profiles', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Changes in fecal microbiome profiles'}], 'primaryOutcomes': [{'measure': 'Taste', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Participants will report taste of the protein bars using a 9-point hedonic scale scored from 1 (dislike extremely) to 9 (like extremely) in a Food Acceptance Questionnaire (FAQ)'}, {'measure': 'Gastrointestinal tolerance', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Gastrointestinal tolerance will be assessed using the Gastrointestinal Tolerability Questionnaire (GTQ) scored on the scale of 0 (absent), 1 (mild), 2 (moderate), or 3 (severe)'}], 'secondaryOutcomes': [{'measure': 'Perceived health', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Overall perceived health will be monitored using self-reported wellness status as determined by PROMIS Global-10 questionnaire scored into a physical and mental health components on the scale of 1 (poor), 2 (fair), 3 (good), 4 (very good), or 5 (excellent).'}, {'measure': 'Fasting insulin', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Blood'}, {'measure': 'Fasting glucose', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Blood'}, {'measure': 'Glycosylated HbA1C', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Blood'}, {'measure': 'triglycerides', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Blood'}, {'measure': 'Cholesterol', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'Blood'}, {'measure': 'Homeostatic Model Assessment of Insulin Resistance', 'timeFrame': 'At baseline and after 2 months (end of study)', 'description': 'The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using fasting glucose (FG) and fasting insulin (FI) levels to evaluate insulin sensitivity as (FG×FI)/22.5.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Acceptance', 'Metabolic Health', 'Immune Cells Activity', 'Microbiome Composition']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'https://doi.org/10.1111/jfpe.70121'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if pulse (pea) protein works similar to animal (whey) protein in protein bars consumed by healthy adults.\n\nThe main questions it aims to answer are: What are the differences in taste and tolerance profiles between pea and whey proteins? What metabolic and immune changes do participants experience while eating them? What gastrointestinal microbiome shifts can be observed in these participants? How incorporation and complexation of polyphenols with these proteins changes the study outcomes?\n\nParticipants will: Consume 1 protein bar with whey protein, pea protein, pea protein with complexed polyphenols, or pea protein with free polyphenols every day for 2 months. Visit the study site at baseline and end of study for checkups and tests. Fill dietary, food acceptance, gastrointestinal tolerance, and global health questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both men and women between the ages of 18-64 years;\n* body mass index of 25 and higher;\n* generally healthy and without a clinically significant condition (diabetes, infectious disease, or cancer);\n* participants must not be pregnant or nursing;\n* participants must not be a tobacco user; and\n* history of allergies or intolerance to protein bar ingredients.\n\nExclusion Criteria:\n\n* body mass index lower than 25;\n* pregnancy or nursing;\n* use of blood sugar lowering medications such as metformin, semaglutide, or insulin;\n* use of dietary supplements with polyphenols;\n* history of allergies or intolerance to protein bar ingredients;\n* noncompliance with the study protocol.'}, 'identificationModule': {'nctId': 'NCT07489118', 'acronym': 'POLYPRO', 'briefTitle': 'Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'North Carolina State University'}, 'officialTitle': 'Impact of Consuming Protein and Polyphenol Bars on Metabolic Health', 'orgStudyIdInfo': {'id': '26377'}, 'secondaryIdInfos': [{'id': '58-3060-1-043', 'type': 'OTHER_GRANT', 'domain': 'USDA ARS Pulse Crop Health Initiative'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whey protein bar', 'description': 'Whey protein bar', 'interventionNames': ['Other: Whey protein bar']}, {'type': 'EXPERIMENTAL', 'label': 'Pea protein bar', 'description': 'Pea protein bar', 'interventionNames': ['Other: Pea protein bar']}, {'type': 'EXPERIMENTAL', 'label': 'Pea protein complexed with polyphenols bar', 'description': 'Pea proteins and complexed with blackcurrant polyphenols as a single ingredient', 'interventionNames': ['Other: Pea protein with complexed polyphenols bar']}, {'type': 'EXPERIMENTAL', 'label': 'Pea protein with free polyphenols', 'description': 'Pea proteins and blackcurrant polyphenols are two independent ingredients', 'interventionNames': ['Other: Pea protein with free polyphenols bar']}], 'interventions': [{'name': 'Whey protein bar', 'type': 'OTHER', 'description': 'Whey protein bar', 'armGroupLabels': ['Whey protein bar']}, {'name': 'Pea protein bar', 'type': 'OTHER', 'description': 'Pea protein bar', 'armGroupLabels': ['Pea protein bar']}, {'name': 'Pea protein with complexed polyphenols bar', 'type': 'OTHER', 'description': 'Pea protein with complexed polyphenols bar', 'armGroupLabels': ['Pea protein complexed with polyphenols bar']}, {'name': 'Pea protein with free polyphenols bar', 'type': 'OTHER', 'description': 'Pea protein with free polyphenols bar', 'armGroupLabels': ['Pea protein with free polyphenols']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Plants for Human Health Institute', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Carolina State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Pharmacogenomics', 'investigatorFullName': 'Slavko Komarnytsky', 'investigatorAffiliation': 'North Carolina State University'}}}}