Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-25 @ 11:52 AM
Study NCT ID:
NCT01033461
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2009-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Probiotic and Calcium in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'faecal microbiota, cholesterol metabolism', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'mineral status, immunological parameters', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['probiotic', 'lactobacillus paracasei', 'calcium', 'faecal microbiota', 'cholesterol metabolism'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '22019281', 'type': 'DERIVED', 'citation': 'Trautvetter U, Ditscheid B, Kiehntopf M, Jahreis G. A combination of calcium phosphate and probiotics beneficially influences intestinal lactobacilli and cholesterol metabolism in humans. Clin Nutr. 2012 Apr;31(2):230-7. doi: 10.1016/j.clnu.2011.09.013. Epub 2011 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone or in combination with a calcium supplement of the human microbiota and further physiological parameters.', 'detailedDescription': 'Animal studies suggest that calcium beneficially influence the microbiota in the gut. This effect of calcium is due to the formation of amorphous calcium phosphate, which has the ability to bind bile acids and other cytotoxic substances in the gut. The precipitation of the cytotoxic substances leads to a less aggressive environment in the gut and might be stimulate the adhesion of the microbiota.\n\nThirty-two healthy men and women participated in a placebo-controlled, double-blind and cross over human study. The participants were randomly divided into two groups. All probands consumed a probiotic drink for four weeks (10e+10 CFU/d). Additionally, one group consumed a pentacalcium phosphate-enriched bread (1 g Ca/d) and the other group consumed a bread without pentacalcium phosphate. After a two-week wash-out and a two-week placebo period the invention changed for another four weeks (cross over). At the end of each intervention and placebo period, subjects consumed a defined diet for three days. Furthermore, there was a three-day quantitative stool and urine collection and a fasting venous blood sample was taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects\n* blood cholesterol concentration \\> 5 mmol/l\n\nExclusion Criteria:\n\n* pregnancy, lactation\n* intake of dietary supplements\n* intake of prebiotics and probiotics\n* chronic diseases'}, 'identificationModule': {'nctId': 'NCT01033461', 'briefTitle': 'Combination of Probiotic and Calcium in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'The Effect of the Probiotic L. Paracasei LPC 37 Alone or in Combination With a Calcium Supplement in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LSEP H33-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'calcium and probiotic', 'description': 'intervention', 'interventionNames': ['Dietary Supplement: calcium and probiotic']}, {'type': 'EXPERIMENTAL', 'label': 'probiotic', 'description': 'intervention', 'interventionNames': ['Dietary Supplement: probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo, no intervention', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'calcium and probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the subjects consumed for 4 weeks a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 and a bread enriched with 1 g pentacalcium phosphate per day', 'armGroupLabels': ['calcium and probiotic']}, {'name': 'probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks', 'armGroupLabels': ['probiotic']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Gerhard Jahreis, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. habil', 'investigatorFullName': 'Gerhard Jahreis', 'investigatorAffiliation': 'University of Jena'}}}}