Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02110602
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intake and Circulating Levels of Branched Chain Amino Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007532', 'term': 'Isoleucine'}, {'id': 'D007930', 'term': 'Leucine'}, {'id': 'D014633', 'term': 'Valine'}], 'ancestors': [{'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of fasting glucose and insulin levels following diet interventions', 'timeFrame': '4 days'}, {'measure': 'Change in fasting glucose and insulin levels from native dietary intake to completion of diet intervention', 'timeFrame': '4 days'}, {'measure': 'Tolerance of diet interventions', 'timeFrame': '4 days'}], 'primaryOutcomes': [{'measure': 'Comparison of Branch Chain Amino Acid levels following diet interventions', 'timeFrame': '4 days', 'description': 'A comparison of branched chain amino acid levels (as measured by mass spectrometry) following 4 days of a low and following 4 days of a high BCAA-content diet'}], 'secondaryOutcomes': [{'measure': 'Change in fasting BCAA levels from native dietary intake to completion of diet intervention', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nutrition'], 'conditions': ['Dietary Intake of Branched Chain Amino Acids']}, 'referencesModule': {'references': [{'pmid': '26781817', 'type': 'DERIVED', 'citation': 'Cavallaro NL, Garry J, Shi X, Gerszten RE, Anderson EJ, Walford GA. A pilot, short-term dietary manipulation of branched chain amino acids has modest influence on fasting levels of branched chain amino acids. Food Nutr Res. 2016 Jan 14;60:28592. doi: 10.3402/fnr.v60.28592. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males\n* Ages 20-40\n* Healthy\n\nExclusion Criteria:\n\n* Age less than 20 or greater than 40\n* Female sex\n* Use of medications and herbal or vitamin supplements during the study or less than one month prior to enrollment in the study\n* Body mass index (BMI) less than 20 or greater than 25\n* Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study\n* Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study or plans for changes in exercise level during the study\n* Known diabetes or pre-diabetes (based on prior diagnoses; use of medications to lower glucose; or fasting blood glucose \\> 100mg/dL at screening)\n* Untreated hypertension (defined as systolic blood pressure \\> 140mmHg and diastolic blood pressure \\> 90mmHg)\n* Use of nicotine-containing products, including those inhaled, chewed, or patches during the study.\n* Use of drugs of abuse.\n* Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric surgery\n* Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation to 1 caffeinated beverage per day\n* Known anemia (men, hematocrit \\< 38%) based on prior testing'}, 'identificationModule': {'nctId': 'NCT02110602', 'briefTitle': 'Dietary Intake and Circulating Levels of Branched Chain Amino Acids', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Short-term Dietary Intake and Branched Chain Amino Acids', 'orgStudyIdInfo': {'id': '2013P002607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Diet - high in amino acid levels', 'description': 'Visit 1 (Day 1): Screening Visit\n\nVisit 2 (14-21 days after Visit 1): Begin high amino acid diet\n\nVisit 3 (4 days after Visit 2): Completion of high amino acid diet\n\nVisit 4 (3 days after Visit 3): Begin low amino acid diet\n\nVisit 5 (4 days after Visit 4): Completion of low amino acid diet, completion of study', 'interventionNames': ['Other: Diet high in amino acid levels', 'Other: Diet low in amino acid levels']}, {'type': 'EXPERIMENTAL', 'label': 'Initial Diet - low in amino acid levels', 'description': 'Visit 1 (Day 1): Screening Visit\n\nVisit 2 (14-21 days after Visit 1): Begin low amino acid diet\n\nVisit 3 (4 days after Visit 2): Completion of low amino acid diet\n\nVisit 4 (3 days after Visit 3): Begin high amino acid diet\n\nVisit 5 (4 days after Visit 4): Completion of high amino acid diet, completion of study', 'interventionNames': ['Other: Diet high in amino acid levels', 'Other: Diet low in amino acid levels']}], 'interventions': [{'name': 'Diet high in amino acid levels', 'type': 'OTHER', 'otherNames': ['Amino Acid supplements to be used in prepared meals:', 'Vitaflo MSUD express', 'l-isoleucine', 'l-leucine', 'l-valine'], 'description': 'Meals will be prepared in the Clinical Research Center Metabolism \\& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.', 'armGroupLabels': ['Initial Diet - high in amino acid levels', 'Initial Diet - low in amino acid levels']}, {'name': 'Diet low in amino acid levels', 'type': 'OTHER', 'description': 'Meals will be prepared in the Clinical Research Center Metabolism \\& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.', 'armGroupLabels': ['Initial Diet - high in amino acid levels', 'Initial Diet - low in amino acid levels']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Geoffrey Walford, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Geoffrey Walford, MD', 'investigatorFullName': 'Geoffrey Walford, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}