Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT02528994
Status:
WITHDRAWN
Last Update Posted:
2016-09-16
First Post:
2015-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Dietary Serine Supplementation and Circulating Serine Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012694', 'term': 'Serine'}], 'ancestors': [{'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The PI will be leaving the institution and not continuing the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating serine levels', 'timeFrame': '14 days', 'description': 'We will measure circulating serine levels after 14 days of intervention'}], 'secondaryOutcomes': [{'measure': 'Supplement tolerability', 'timeFrame': '14 days', 'description': 'We will assess tolerability of dietary serine supplements after 14 days of intervention'}, {'measure': 'Fasting and post-prandial glucose', 'timeFrame': '14 days', 'description': 'We will assess fasting and post-prandial glucose after 14 days of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dietary supplements', 'Metabolism'], 'conditions': ['Serine']}, 'descriptionModule': {'briefSummary': 'This study will test the effect of short-term, high-dose dietary serine supplementation on circulating levels of serine. Individuals with risk factors for type 2 diabetes will be recruited into the 2 week study. Effects of dietary serine supplementation on glycemic measures will also be explored.', 'detailedDescription': 'This is a single-center, open-label, randomized, nutritional intervention study in adults. Subjects will have three visits to the Massachusetts General Hospital Clinical Research Center (CRC) during the 2 week study.\n\nAt the first study visit (Visit 1), the following will occur: informed consent; medical and nutritional history assessment; blood pressure, weight and height, fasting blood draw and blood work during a 2 hr oral glucose tolerance test; explanation and instructions for completion of a 4-day food log; randomized assignment to dose of dietary serine supplementation (6g, 12g, 24g, or 48g); provide 7 days of dietary serine supplements; take first dose of supplement with snack; schedule Visit 2 and Visit 3.\n\nBetween Visit 1 and Visit 2, participants will complete the Food Log and take the assigned dose of dietary serine supplementation 3 times daily.\n\nVisit 2 will occur 7 days after Visit 1. Subjects will not take dietary serine supplementation prior to Visit 2 activities. At Visit 2, the following will occur: weight and blood pressure; fasting blood draw; administration of assigned dose of dietary serine supplementation with snack after blood work; review of the 4-day food log; provide 7 days of dietary serine supplements completion of anonymous survey to assess tolerability of supplement. Participants will continue to take the assigned dose of dietary serine supplementation 3 times daily between Visit 2 and Visit 3.\n\nVisit 3 will occur 7 days after Visit 2. At Visit 3, the following will occur: weight and blood pressure; review of the 4-day food log; fasting blood draw and blood work during a 2 hr oral glucose tolerance test; completion of study survey to assess tolerability of the supplement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* risk factors for type 2 diabetes\n\nExclusion Criteria:\n\n* known type 2 diabetes\n* women who are pregnant, nursing, or not using contraception or abstinence\n* taking amino acid supplements during the study or at any time 1 month prior to enrollment in the study\n* conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery\n* known active liver disease\n* currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones\n* participation in any other interventional study during the study duration\n* inability to adhere to study protocol.'}, 'identificationModule': {'nctId': 'NCT02528994', 'briefTitle': 'Short Term Dietary Serine Supplementation and Circulating Serine Levels', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels', 'orgStudyIdInfo': {'id': '2014D001170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serine 6g daily', 'description': 'Randomized participants will take 6g daily of dietary serine supplement', 'interventionNames': ['Dietary Supplement: L-serine']}, {'type': 'EXPERIMENTAL', 'label': 'Serine 12g daily', 'description': 'Randomized participants will take 12g daily of dietary serine supplement', 'interventionNames': ['Dietary Supplement: L-serine']}, {'type': 'EXPERIMENTAL', 'label': 'Serine 24g daily', 'description': 'Randomized participants will take 24g daily of dietary serine supplement', 'interventionNames': ['Dietary Supplement: L-serine']}, {'type': 'EXPERIMENTAL', 'label': 'Serine 48g daily', 'description': 'Randomized participants will take 48g daily of dietary serine supplement', 'interventionNames': ['Dietary Supplement: L-serine']}], 'interventions': [{'name': 'L-serine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take dietary serine supplementation daily', 'armGroupLabels': ['Serine 12g daily', 'Serine 24g daily', 'Serine 48g daily', 'Serine 6g daily']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geoffrey A Walford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Geoffrey Walford, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}