Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT04848233
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2021-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glucose response', 'timeFrame': 'From start of meal (0 min) to 120 min postprandially', 'description': 'Incremental area under the blood glucose curve after each meal'}], 'secondaryOutcomes': [{'measure': 'Glycemic variability', 'timeFrame': '24 hour cycles', 'description': 'Variation in blood glucose levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycemic Control', 'Diet, Food and Nutrition']}, 'referencesModule': {'references': [{'pmid': '36062264', 'type': 'RESULT', 'citation': 'Samigullin A, Humpert PM, Ostman E. Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium. Front Med Technol. 2022 Aug 18;4:931837. doi: 10.3389/fmedt.2022.931837. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25-29.9 kg/m\\^2\n* HOMA-IR \\< 2.5\n* Fasting glucose \\< 6.1 mmol/L\n* Stable weight since 3 months\n* Access to iPhone with Bluetooth 4.0 and iOS 13 or later\n\nExclusion Criteria:\n\n* Diabetes\n* Pharmacological treatment known to interfer with metabolism\n* Antibiotics treatment the latest 3 months\n* Vegetarian/Vegan diet\n* Use of tobacco\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT04848233', 'briefTitle': 'Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans', 'organization': {'class': 'INDUSTRY', 'fullName': 'DoubleGood AB'}, 'officialTitle': 'Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial', 'orgStudyIdInfo': {'id': 'DG2101_CGM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Drink intervention', 'description': 'Placebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order.', 'interventionNames': ['Dietary Supplement: Drinks containing 5AA+CrPic and Placebo']}], 'interventions': [{'name': 'Drinks containing 5AA+CrPic and Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.', 'armGroupLabels': ['Drink intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223 63', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Aventure AB', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Elin Ostman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aventure AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DoubleGood AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'starScience GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}