Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 1:03 PM
Study NCT ID:
NCT04229069
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acid-Base Balance, Metabolism and Minerals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C457581', 'term': 'basica'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle dialysate lactate-pyruvate ratio', 'timeFrame': 'before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal', 'description': 'surrogate measure for muscle tissue pH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acid-base balance', 'energy metabolism', 'protein-rich diet', 'alkaline supplementation', 'calorimetry', 'microdialysis', 'randomized placebo-controlled trial'], 'conditions': ['Acid-Base Balance Disorder', 'Metabolic Acidosis']}, 'descriptionModule': {'briefSummary': 'Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.\n\nWithin a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* slightly reduced kidney function (GFR 60-89 ml/min)\n* Body mass index 20.0 - 29.9 kg/m2\n* normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively\n\nExclusion Criteria:\n\n* sorbitol-/fructose-intolerance\n* intake of antacidic drugs\n* vegetarians, vegans\n* intake of any nutritional supplements\n* any cardiovascular, pulmonary, endocrine or metabolic diseases\n* any drug abuse\n* intake of any anticoagulant drugs'}, 'identificationModule': {'nctId': 'NCT04229069', 'acronym': 'BASICA', 'briefTitle': 'Acid-Base Balance, Metabolism and Minerals', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'BASICA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Basica', 'description': '4-week dietary supplementation with an alkaline salt (Basica)', 'interventionNames': ['Dietary Supplement: alkaline salt mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4-week dietary supplementation with a placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'alkaline salt mixture', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Basica'], 'description': 'blood and tissue alkalinisation', 'armGroupLabels': ['Basica']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'no blood and tissue alkalinisation', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Boschmann', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}