Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01240018
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2010-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ProSat - Long Term Effect of Probiotics on Satiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen.', 'timeFrame': 'June 2011'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite measurements, spontaneous food intake.', 'timeFrame': 'June 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Appetite Regulation']}, 'descriptionModule': {'briefSummary': 'The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Normal to slight overweight (BMI: 22-28 kg/m2)\n* 20-45 years of age\n\nExclusion Criteria:\n\n* Smoking\n* Daily medicine use (oral contraceptives excluded)\n* Use of pre- and probiotic supplements and foods\n* Blood donation 3 months prior to the study\n* Hb \\< 7,5mmol/l\n* Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases\n* Pregnancy or breastfeeding\n* Elite athletes (\\>10 hours hard exercise/week)\n* Vegetarians'}, 'identificationModule': {'nctId': 'NCT01240018', 'acronym': 'ProSat', 'briefTitle': 'ProSat - Long Term Effect of Probiotics on Satiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Probiotics and Satiety - Acute Effects and Persistence of Acute Effects', 'orgStudyIdInfo': {'id': 'B257II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose Lb. casei', 'interventionNames': ['Dietary Supplement: Probiotic']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Parallel, randomized, controlled 2 arms study.', 'armGroupLabels': ['High dose Lb. casei', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'state': 'DK', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Human Nutrition', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Arne Astrup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, Copenhagen University, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'AAstrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}