Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT02094768
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2014-03-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soda and Milk Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D000080845', 'term': 'Sugar-Sweetened Beverages'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL peak particle diameter', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Plasma triglycerides', 'timeFrame': '3 weeks'}, {'measure': 'LDL-cholesterol', 'timeFrame': '3 weeks'}, {'measure': 'HDL-cholesterol', 'timeFrame': '3 weeks'}, {'measure': 'Blood pressure', 'timeFrame': '3 weeks', 'description': 'Systolic and diastolic'}, {'measure': 'LDL subclass concentrations', 'timeFrame': '3 weeks'}, {'measure': 'Apolipoprotein B', 'timeFrame': '3 weeks'}, {'measure': 'Apolipoprotein AI', 'timeFrame': '3 weeks'}, {'measure': 'Apolipoprotein CIII', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males, age 13-18\n* Tanner stage ≥ 2\n* Self reported sugar sweetened beverage intake 24oz to 60oz per day\n* Self reported milk intake ≤16 oz. per day\n* BMI 85-99 percentile for age\n* Tolerant to milk\n\nExclusion Criteria:\n\n* History or diagnosis of hypertension or taking blood pressure lowering medication\n* History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl\n* Fasting triglyceride \\> 300 mg/dl\n* On lipid lowering or diabetes medication'}, 'identificationModule': {'nctId': 'NCT02094768', 'acronym': 'SAMS', 'briefTitle': 'Soda and Milk Study', 'organization': {'class': 'OTHER', 'fullName': "UCSF Benioff Children's Hospital Oakland"}, 'officialTitle': 'Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents', 'orgStudyIdInfo': {'id': 'MM7267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Fat Milk', 'description': '20 oz. reduced fat (2%) milk per day', 'interventionNames': ['Dietary Supplement: Reduced Fat Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Sugar Sweetened Soda', 'description': '24oz. soda per day', 'interventionNames': ['Dietary Supplement: Sugar Sweetened Soda']}], 'interventions': [{'name': 'Reduced Fat Milk', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['2% milk'], 'description': 'Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks', 'armGroupLabels': ['Reduced Fat Milk']}, {'name': 'Sugar Sweetened Soda', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['High fructose corn syrup sweetened soda'], 'description': 'Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks', 'armGroupLabels': ['Sugar Sweetened Soda']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Cholesterol Research Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Ronald M Krauss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, 'collaborators': [{'name': 'Almond Board of California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}