Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-05 @ 7:56 AM
Study NCT ID:
NCT02542033
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2015-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Response to Low Sugar Apple Juice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incremental area under the postprandial glucose curve', 'timeFrame': '120 min postprandially'}], 'secondaryOutcomes': [{'measure': 'incremental area under the postprandial insulin curve', 'timeFrame': '120 min postprandially'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postprandial glycemia; apple juice; sugar reduction'], 'conditions': ['Impaired Fasting Glucose']}, 'descriptionModule': {'briefSummary': 'Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response.\n\nExploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.', 'detailedDescription': 'Objectives:\n\nInvestigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink.\n\nSubjects/Methods:\n\nIn a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males aged ≥ 18y\n2. diagnosed impaired fasting glucose (IFG)\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Subjects currently enrolled in another clinical study\n2. Subjects having finished another clinical study within the last 4 weeks before inclusion\n3. Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food\n4. Acute or chronic infections\n5. Renal insufficiency\n6. Gastrointestinal illness\n7. History of gastrointestinal surgery\n8. Known fructose intolerance\n9. Overt Diabetes mellitus\n10. Endocrine disorders\n11. Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body System with the exception of the conditions defined by the inclusion criteria\n12. History of hepatitis B and C\n13. History of HIV infection\n14. History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)\n15. Regular medical treatment including OTC, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.)\n16. Major cognitive or psychiatric disorders\n17. Subjects who are scheduled to undergo hospitalization during the study period\n18. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)\n19. Present drug abuse or alcoholism\n20. Legal incapacity'}, 'identificationModule': {'nctId': 'NCT02542033', 'briefTitle': 'Glycemic Response to Low Sugar Apple Juice', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Research Center Kiel GmbH'}, 'officialTitle': 'Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice', 'orgStudyIdInfo': {'id': 'HB-RCT1-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'verum', 'description': '500mL treated apple juice with low sugar content given on one experimental day', 'interventionNames': ['Other: treated apple juice with low sugar content']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '500mL un-treated apple juice with normal sugar content given on one experimental day', 'interventionNames': ['Other: un-treated apple juice with normal sugar content']}], 'interventions': [{'name': 'treated apple juice with low sugar content', 'type': 'OTHER', 'description': 'Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.', 'armGroupLabels': ['verum']}, {'name': 'un-treated apple juice with normal sugar content', 'type': 'OTHER', 'description': 'Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24118', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Clinical Research Center (CRC) Kiel GmbH', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Research Center Kiel GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nofima', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}