Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 4:39 AM
Study NCT ID:
NCT04796259
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Malt-derived Ingredients and Their Prolactinotrophic Effects
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolactinotrophic effect', 'timeFrame': '2 hours post consumption', 'description': 'Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal tolerability', 'timeFrame': '2 hours post consumption', 'description': '• Gastro-intestinal tolerability assessment with a visual analogue scale for each symptom of interest i.e.1) Abdominal discomfort 2) Nausea 3) Vomiting 4) Diarrhoea 5) ↓appetite.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Response to Food Ingredient Consumption']}, 'descriptionModule': {'briefSummary': 'This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have/are\n\n 1. Willing and able to provide written informed consent\n 2. Healthy women aged 18 to 40.\n 3. BMI in the range of 18 to 30.\n 4. Willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period.\n\nExclusion Criteria:\n\n* Subjects who have/are\n* Allergic to tested products\n* Under regular medication including oral contraceptive pills or other form of hormonal replacement therapy.\n* Under medications which affects prolactin levels.\n* Pregnant or lactating or planning to conceive during the study period.\n* Smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse.\n* Not willing and/or not able to comply with the study procedures and requirements.\n* Suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study.\n* Family or hierarchical relationships with research team members'}, 'identificationModule': {'nctId': 'NCT04796259', 'briefTitle': 'Malt-derived Ingredients and Their Prolactinotrophic Effects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Malt-derived Ingredients and Their Prolactinotrophic Effects', 'orgStudyIdInfo': {'id': '20.21.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Negative control', 'description': 'Water'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control', 'description': 'Non-alcoholic beer solids', 'interventionNames': ['Dietary Supplement: Non-alcoholic beer solids']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 1', 'description': 'Malt ingredient I', 'interventionNames': ['Dietary Supplement: Malt ingredient']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 2', 'description': 'Malt ingredient II', 'interventionNames': ['Dietary Supplement: Malt ingredient']}], 'interventions': [{'name': 'Malt ingredient', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Solution with malt-derived ingredient', 'armGroupLabels': ['Intervention 1', 'Intervention 2']}, {'name': 'Non-alcoholic beer solids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Solution with non-alcoholic beer solids', 'armGroupLabels': ['Positive control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Société des produits Nestlé/Metabolic Unit', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Jose M. Ramos Nieves, M.Sc.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Société des Produits Nestlé S.A./NIHS'}, {'name': 'Pamela Sun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Société des Produits Nestlé S.A./CIL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}