Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-03-28 @ 8:27 AM
Study NCT ID:
NCT02403804
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2015-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Supplementation to Increase Serum Choline Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010713', 'term': 'Phosphatidylcholines'}, {'id': 'D001622', 'term': 'Betaine'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in serum choline', 'timeFrame': '4 hours post supplement.- baseline'}], 'secondaryOutcomes': [{'measure': 'change in serum choline', 'timeFrame': '2 hours post supplementation.- baseline'}, {'measure': 'change in serum choline', 'timeFrame': '6 hours post supplementation.- baseline'}, {'measure': 'change in serum choline', 'timeFrame': '8 hours post supplementation.- baseline'}, {'measure': 'change in serum choline', 'timeFrame': '10 hours post supplementation.- baseline'}, {'measure': 'change in serum choline', 'timeFrame': '12 hours post supplementation - baseline'}, {'measure': 'change in serum choline', 'timeFrame': '1 week post supplementation - baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dietary supplements', 'serum choline', 'women'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The goal is to assess whether, in adult women during the luteal phase of their menstrual cycle, supplementing their diet with either phosphatidylcholine or betaine increases their serum choline levels.', 'detailedDescription': 'Elevated maternal serum free choline has the potential to improve fetal brain development . However, in humans, choline can be metabolized by gut flora into two metabolites with adverse outcomes: trimethylurea (which causes body odor) and Trimethylamine (TMA) which is then, once absorbed, metabolized into Trimethylamine-N-Oxide (TMAO). There is some concern that TMAO may be atherogenic and thus, if elevated over an extended period of time, may increase risk for cardiac disease. Thus, while maternal choline supplementation may improve fetal brain development, there is a potential for maternal adverse effects.\n\nHowever, humans have an active choline metabolic pathway, and other components of the choline metabolic pathway (e.g. phosphatidylcholine and betaine) may be interchangeable with choline post absorption but are resistant to gut bacteria metabolism (i.e. serum TMA does not increase). Thus, these other compounds would be expected to increase serum but with no impact on TMA or trimethylurea levels. An initial study of phosphatidylcholine supplementation in pregnant women was consistent with this hypothesis; infant offspring demonstrated improved cerebral inhibition; while no adverse events were identified for either mother or infant.\n\nUnfortunately, because of the lipid groups incorporated into phosphatidylcholine, its molecular weight is high and reasonable doses require consuming several large capsules a day. The study represents the first attempt to determine if betaine, an alternative compound within the same metabolic pathway but with a much lower molecular weight, also increases serum choline levels. As the first step, this proposal seeks to address this in non-pregnant women. Specifically, the goals are to (a) assess whether changes in serum choline levels in response to molar equivalent supplementation of phosphatidylcholine versus betaine are similar, and (b) whether, for betaine, there is a dose response relationship between supplementation dose and serum choline levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. premenopausal\n2. No nicotine use\n3. No marijuana use\n4. No illicit substance use\n5. Weight \\>= 90 pounds\n\nExclusion Criteria:\n\n1. self-reported body odor of unknown etiology\n2. personal or family history of cystathionine beta synthase deficiency (homocystinuria)\n3. personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT02403804', 'briefTitle': 'Dietary Supplementation to Increase Serum Choline Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Dietary Supplementation to Increase Serum Choline Levels', 'orgStudyIdInfo': {'id': '14-1783'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'All 3 weeks will occur during luteal phase of menstrual cycle with a two-to-three week washout period between weeks.\n\nWeek 1: Phosphatidylcholine 3600 mg qam and 2700 mg qpm\n\nWeek 2: Betaine anhydrous 588 mg qam and 412 mg qpm\n\nWeek 3: Betaine anhydrous 1000 mg BID', 'interventionNames': ['Dietary Supplement: Phosphatidylcholine', 'Dietary Supplement: Betaine (588 mg qam and 412 mg qpm)', 'Dietary Supplement: Betaine (1000 mg BID)']}], 'interventions': [{'name': 'Phosphatidylcholine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Phosphatidylcholine 3600 mg qam and 2700 mg qpm', 'armGroupLabels': ['All subjects']}, {'name': 'Betaine (588 mg qam and 412 mg qpm)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Trimethylglycine'], 'description': 'Betaine anhydrous 588 mg qam and 412 mg qpm', 'armGroupLabels': ['All subjects']}, {'name': 'Betaine (1000 mg BID)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Trimethylglycine'], 'description': 'Betaine anhydrous 1000 mg BID', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Camille Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health and Hospitals'}, {'name': 'Randal G Ross, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Colorado School of Medicine'}, {'name': 'Ann Olincy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}