Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-31 @ 8:25 PM
Study NCT ID:
NCT04067466
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of satiety using objective methods (blood analysis)', 'timeFrame': 'Change from week 1 to week 2', 'description': 'Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)'}, {'measure': 'Assessment of satiety (blood analysis)', 'timeFrame': 'Change from week 1 to week 2', 'description': 'Biochemistry : GOT and GPT (UI/L)'}, {'measure': 'Assessment of satiety using a subjective method (visual analogue scale)', 'timeFrame': 'Change from week 1 to week 2', 'description': 'The perceived feeling of satiety will be measured using the 100mm "Visual Analogue Scale" labeled at a far end with a "mark" to the left of "extremely hungry", and on the other with an "extremely satiated"."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Satiety', 'Appetite']}, 'descriptionModule': {'briefSummary': 'This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones', 'detailedDescription': 'This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between 15 and 30 years old.\n* Subjects with IMC\\<25 kg/m2\n* Subjects who have a habit of having breakfast, lunch and dinner every day\n* Subjects who are willing to comply with the study procedures\n\nExclusion Criteria:\n\n* Subjects taht are taking any medicines that affect the appetite or food intake\n* Presence of endocrine-metabolic diseases\n* Eating disorders\n* Subjects who are following a special diet\n* Subjects who have changed their body weight by more than 10% in the last three months prior to the study\n* Subjects who follow a restrictive dietary pattern such as vegetarians, gluten-free diets, weight loss diets, etc.'}, 'identificationModule': {'nctId': 'NCT04067466', 'briefTitle': 'Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Ordesa'}, 'officialTitle': 'Effect on Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group', 'orgStudyIdInfo': {'id': 'VEGYDOWN-15 (B)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber product', 'description': 'Fiber product: Inulin, maltodextrin, gum guar, plum powder', 'interventionNames': ['Dietary Supplement: Fiber product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control product', 'description': 'Maltodextrin, plum powder', 'interventionNames': ['Dietary Supplement: Control product']}], 'interventions': [{'name': 'Fiber product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fiber product with inulin, maltodextrin, gum guar and plum powder.', 'armGroupLabels': ['Fiber product']}, {'name': 'Control product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo product with maltodextrin and plum powder', 'armGroupLabels': ['Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'state': 'Aragon', 'country': 'Spain', 'facility': 'GENUD Research Group, Universidad de Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Luis Moreno Aznar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}