Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03467503
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Diet for Healthy Moms and Babies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721609', 'term': 'blueberry extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maternal metabolomics', 'timeFrame': '20 weeks', 'description': 'Maternal serum NMR metabolites'}], 'primaryOutcomes': [{'measure': 'Gestational weight gain', 'timeFrame': '20 weeks', 'description': 'Maternal weight gain in lbs'}, {'measure': 'Gestational glycemia', 'timeFrame': '20 weeks', 'description': 'Maternal blood glucose and HbA1c as measures of glycemia'}, {'measure': 'Maternal serum lipids', 'timeFrame': '20 weeks', 'description': 'Conventional total, LDL-cholesterol and their particle size to describe lipid profiles'}, {'measure': 'Maternal inflammation', 'timeFrame': '20 weeks', 'description': 'C-reactive protein as a stable biomarker of inflammation'}], 'secondaryOutcomes': [{'measure': 'Maternal biomarkers of atherosclerosis', 'timeFrame': '20 weeks', 'description': 'Serum cytokines measured as interleukins and adipokines'}, {'measure': 'Maternal dietary intakes', 'timeFrame': '20 weeks', 'description': 'Maternal intakes of energy intake and nutrients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Obesity', 'Pregnancy, High Risk']}, 'referencesModule': {'references': [{'pmid': '33693835', 'type': 'DERIVED', 'citation': 'Basu A, Feng D, Planinic P, Ebersole JL, Lyons TJ, Alexander JM. Dietary Blueberry and Soluble Fiber Supplementation Reduces Risk of Gestational Diabetes in Women with Obesity in a Randomized Controlled Trial. J Nutr. 2021 May 11;151(5):1128-1138. doi: 10.1093/jn/nxaa435.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Pregnancy study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> or = 30, \\<20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes\n\nExclusion Criteria:\n\n* • Twin or multiple pregnancy\n\n * Chronic pre-pregnancy conditions (CHD, cancer, diabetes)\n * Gastrointestinal conditions\n * Anemia\n * Allergic to berries and fiber\n * Vegetarian food habits or special diets\n * Not proficient in English and/or unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03467503', 'briefTitle': 'Healthy Diet for Healthy Moms and Babies', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Healthy Diet for Healthy Moms and Babies', 'orgStudyIdInfo': {'id': '1155039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Prenatal Care/Nutrition Education', 'description': 'Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.'}, {'type': 'EXPERIMENTAL', 'label': 'Dietary Intervention', 'description': 'Participants were given dietary blueberries (2 cups) and soluble fiber (12g). They also received nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.', 'interventionNames': ['Dietary Supplement: Blueberry + soluble fiber']}], 'interventions': [{'name': 'Blueberry + soluble fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary frozen blueberries and soluble fiber for 20 weeks', 'armGroupLabels': ['Dietary Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89154', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada at Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Arpita Basu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nevada at Las Vegas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arpita Basu', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}