Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT05213559
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010940', 'term': 'Plant Proteins'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in postprandial glucose response', 'timeFrame': 'Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.', 'description': 'change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.'}], 'secondaryOutcomes': [{'measure': 'change in postprandial appetite regulating hormone responses', 'timeFrame': 'Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.', 'description': 'changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cereal-based biscuit enriched with plant proteins', 'appetite regulation', 'glycemic control', 'hormone responses'], 'conditions': ['Appetite']}, 'descriptionModule': {'briefSummary': 'Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.', 'detailedDescription': 'Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.\n\nAt the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Eligibility is based on gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-diabetic women with overweight/obesity\n* constant body weight for the last three months before enrollment\n* standard dietary and physical activity habits\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* chronic medical illness\n* use of nutritional supplements\n* alcohol consumption \\>2 drinks per day'}, 'identificationModule': {'nctId': 'NCT05213559', 'briefTitle': 'Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit', 'organization': {'class': 'OTHER', 'fullName': 'Harokopio University'}, 'officialTitle': 'Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins', 'orgStudyIdInfo': {'id': '26.14-2-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wheat-based biscuit enriched with plant proteins', 'description': 'Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily.', 'interventionNames': ['Other: wheat biscuit enriched with plant proteins']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'wheat biscuit', 'description': 'Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily.', 'interventionNames': ['Other: common wheat biscuit']}], 'interventions': [{'name': 'wheat biscuit enriched with plant proteins', 'type': 'OTHER', 'description': 'Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins', 'armGroupLabels': ['wheat-based biscuit enriched with plant proteins']}, {'name': 'common wheat biscuit', 'type': 'OTHER', 'description': 'Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit', 'armGroupLabels': ['wheat biscuit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Alexander Kokkinos, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}, {'name': 'Amalia Yanni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harokopio University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harokopio University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amalia Yanni', 'investigatorAffiliation': 'Harokopio University'}}}}