Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-26 @ 7:18 PM
Study NCT ID:
NCT01580150
Status:
COMPLETED
Last Update Posted:
2012-04-18
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Berries on Post-meal Blood Sugar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005638', 'term': 'Fruit'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '0, 15, 30, 45, 60, 90, 120 minutes post-meal'}, {'measure': 'Plasma insulin', 'timeFrame': '0, 15, 30, 45, 60, 90, 120 minutes post-meal'}], 'secondaryOutcomes': [{'measure': 'Plasma free fatty acids', 'timeFrame': '0, 15, 30, 45, 60, 90, 120 minutes post-meal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Berries', 'Starch', 'Sucrose', 'Glucose', 'Insulin', 'Postprandial'], 'conditions': ['Blood Glucose, Postprandial', 'Blood Insulin, Postprandial', 'Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '23365108', 'type': 'DERIVED', 'citation': 'Torronen R, Kolehmainen M, Sarkkinen E, Poutanen K, Mykkanen H, Niskanen L. Berries reduce postprandial insulin responses to wheat and rye breads in healthy women. J Nutr. 2013 Apr;143(4):430-6. doi: 10.3945/jn.112.169771. Epub 2013 Jan 30.'}, {'pmid': '22854401', 'type': 'DERIVED', 'citation': 'Torronen R, Kolehmainen M, Sarkkinen E, Mykkanen H, Niskanen L. Postprandial glucose, insulin, and free fatty acid responses to sucrose consumed with blackcurrants and lingonberries in healthy women. Am J Clin Nutr. 2012 Sep;96(3):527-33. doi: 10.3945/ajcn.112.042184. Epub 2012 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.', 'detailedDescription': 'Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.\n\nThe purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:\n\n* Studies 1-2: white wheat bread (starch) is consumed with several berry species\n* Study 3: white wheat bread or rye bread is consumed with a mixture of berries\n* Study 4: sugar (sucrose) is consumed with berries and berry nectars\n* Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 20-28 kg/m2\n* normal fasting plasma glucose\n\nExclusion Criteria:\n\n* Smoking\n* Diabetes or other chronic disease\n* Antibiotic medication within the past 3 months\n* Blood donation within the past month'}, 'identificationModule': {'nctId': 'NCT01580150', 'acronym': 'SOMA', 'briefTitle': 'Effects of Berries on Post-meal Blood Sugar', 'organization': {'class': 'OTHER', 'fullName': 'University of Eastern Finland'}, 'officialTitle': 'Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch', 'orgStudyIdInfo': {'id': '247032'}, 'secondaryIdInfos': [{'id': '70035/09, 1087/31/2009', 'type': 'OTHER_GRANT', 'domain': 'Tekes'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Berry meal', 'description': 'Carbohydrate meals with berries', 'interventionNames': ['Other: Berries']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference meal', 'description': 'Carbohydrate meals without berries', 'interventionNames': ['Other: No berries']}], 'interventions': [{'name': 'Berries', 'type': 'OTHER', 'description': 'Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).', 'armGroupLabels': ['Berry meal']}, {'name': 'No berries', 'type': 'OTHER', 'description': 'Meals containing starch (bread) or sucrose are consumed without berries.', 'armGroupLabels': ['Reference meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI-70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'University of Eastern Finland', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Riitta Törrönen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marjukka Kolehmainen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior scientist', 'investigatorFullName': 'Marjukka Kolehmainen', 'investigatorAffiliation': 'University of Eastern Finland'}}}}