Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03831893
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2019-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Nopal in Healthy Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose tolerance', 'timeFrame': '3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)', 'description': 'Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance.'}], 'secondaryOutcomes': [{'measure': 'subjective appetite sensations', 'timeFrame': '3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)', 'description': 'changes in subjective appetite sensations will be registered in the postprandial period at breakfast, using 0 - 100 mm visual analogue scales (VAS scale). The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a appetite sensation. The hunger sensations to measure are: hunger, satiety and desire to eat.The area under the curve are used in the statistical evaluation to determine'}, {'measure': 'Mood', 'timeFrame': '3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)', 'description': 'Changes in mood parameters (valence and activity) will be registered in the postprandial period after breakfast.The mood measurements will be assessed using the Swedish Core Affect Scale which included three self-reporting rating scales for evaluating valence (unpleasantness-pleasantness) and for activation (quietness-excitement), respectively. The subjective mood ratings are registered using 0 mm-100 mm VAS. The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a sensation to be rated.The valence rating is assessed by obtaining a mean rating of three scales graded from displeased-pleased, sad-glad and depressed-happy, respectively, and the rating of activation is assessed by obtaining a mean rating of three scales graded from sleepy-awake, passive-active and dull-peppy, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the purpose of this study is to evaluate effects on metabolic test markers of Nopal (Opuntia) in healthy humans.', 'detailedDescription': 'The study include three visits at the research unit. At two of the visits the test subjects consume nopal in different doses. At one visit the subjects will consume a reference product. The intervention products are consumed at breakfast (at 8.00) and metabolic effects are investigated 3 hours postprandially. Consumption of the intervention products is separated by a one week washout period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations.\n\nExclusion Criteria:\n\nFasting blood glucose \\>6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..'}, 'identificationModule': {'nctId': 'NCT03831893', 'briefTitle': 'Metabolic Effects of Nopal in Healthy Humans', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables', 'orgStudyIdInfo': {'id': '2019-00980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'A food product similar to the test products but without nopal', 'interventionNames': ['Other: control']}, {'type': 'EXPERIMENTAL', 'label': 'Nopal food product 1', 'description': 'Food product with Nopal', 'interventionNames': ['Other: Nopal food product 1']}, {'type': 'EXPERIMENTAL', 'label': 'Nopal food product 2', 'description': 'Food product with Nopal', 'interventionNames': ['Other: Nopal food product 2']}], 'interventions': [{'name': 'Nopal food product 1', 'type': 'OTHER', 'description': 'Dried Nopal incorporated in a food product', 'armGroupLabels': ['Nopal food product 1']}, {'name': 'Nopal food product 2', 'type': 'OTHER', 'description': 'Dried Nopal incorporated in a food product', 'armGroupLabels': ['Nopal food product 2']}, {'name': 'control', 'type': 'OTHER', 'description': 'Food Product without nopal', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Food Technology, engineering and Nutrition, LTH, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anne Nilsson', 'investigatorAffiliation': 'Lund University'}}}}