Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT05702359
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2023-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind (both the investigator and the participant was not aware of the treatment)'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capillary blood glucose responses', 'timeFrame': '3 hours', 'description': 'Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 3hr glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'Salivary insulin responses', 'timeFrame': '3 hours', 'description': 'Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 3hr glucose torelance test'}, {'measure': 'Subjective appetite rating', 'timeFrame': '3 hours', 'description': 'Useful change in subjective appetite using visual analogue scales (VAS). Participants rated their hunger, desire to eat, perceived fullness, thirst, preoccupation with food, pleasure of eating the consumed test food, and thirst, after eating on a horizontal line VAS, with a line length of 10 cm, a line width of 3 desktop publishing points, was black, had flat line endpoints, had an ascending numerical order of scale endpoints \\[i.e., "0" and "10", for example neither hungry (0 mm), full (100 mm) or have desire for food in the middle (50 mm)\\], and used "0" and "10" as numerical anchors below the left and right endpoints, respectively.'}, {'measure': 'Blood pressure', 'timeFrame': '3 hours', 'description': 'Useful change in systolic and diastolic blood pressure before and 3hr after consumption of the juices.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood glucose', 'insulin', 'glycemic index', 'glycemic load', 'juices', 'probiotics', 'vitamin D3', 'n-3 fatty acids'], 'conditions': ['Potential Abnormality of Glucose Tolerance', 'Appetite Disorders']}, 'descriptionModule': {'briefSummary': 'This study investigated the short-term effects of fruit juice enriched with Vitamin D3 or n-3 PUFA or probiotics and the combination of the three ingredients on glucose metabolism.', 'detailedDescription': 'This study aimed to 1. Determine the glycemic index and glycemic load of mixed fruit juice (pomegranate, grape, apple, and orange) enriched with Vitamin D3 or n-3 PUFA or probiotics, and the combination of the three bio-functional ingredients, compared to regular mixed fruit juice and the reference food (D-glucose), and 2.Examine the short-term effects of the five mixed fruit juices on postprandial blood glucose and salivary insulin responses, blood pressure, and subjective appetite, in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Non-smoking\n* Non-diabetic men and women\n* Body mass index between 18.5 and 25 kg.m2\n\nExclusion Criteria:\n\n* Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)\n* Gastrointestinal disorders\n* Pregnancy\n* Lactation\n* Competitive sports\n* Alcohol abuse\n* Drug dependency'}, 'identificationModule': {'nctId': 'NCT05702359', 'briefTitle': 'Acute Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Agricultural University of Athens'}, 'officialTitle': 'Acute Effects of Fruit Juice Enriched With Vitamin D3 or n-3 Fatty Acids or Probiotics and the Combination of the Three Ingredients on Glucose Metabolism in Healthy Adults', 'orgStudyIdInfo': {'id': 'HRBD 78 12.10.2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose as reference food', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Glucose as reference food']}, {'type': 'EXPERIMENTAL', 'label': 'Control juice', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from control mixed fruit juice (pomegranate, grape, apple and orange), tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Control juice']}, {'type': 'EXPERIMENTAL', 'label': 'Juice containing vitamin D3', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with vitamin D3, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Juice with vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': 'Juice containing n-3 polyunsaturated fatty acids (PUFA)', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with n-3 PUFA, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Juice with n-3 fatty acids']}, {'type': 'EXPERIMENTAL', 'label': 'Juice containing probiotics', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with probiotics, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Juice with probiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Juice containing probiotics, vitamin D3, and n-3 PUFA', 'description': 'Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from a mixed juice enriched with probiotics, vitamin D3, and n-3 PUFA, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.', 'interventionNames': ['Other: Juice with probiotics, vitamin D3, and n-3 fatty acids']}], 'interventions': [{'name': 'Glucose as reference food', 'type': 'OTHER', 'otherNames': ['reference drink D-Glucose'], 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g glucose diluted in 300mL water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Glucose as reference food']}, {'name': 'Control juice', 'type': 'OTHER', 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Control juice']}, {'name': 'Juice with vitamin D3', 'type': 'OTHER', 'otherNames': ['Vitamin D3'], 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing vitamin D3, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Juice containing vitamin D3']}, {'name': 'Juice with n-3 fatty acids', 'type': 'OTHER', 'otherNames': ['n-3 fatty acids'], 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing n-3 fatty acids, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Juice containing n-3 polyunsaturated fatty acids (PUFA)']}, {'name': 'Juice with probiotics', 'type': 'OTHER', 'otherNames': ['probiotics'], 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Juice containing probiotics']}, {'name': 'Juice with probiotics, vitamin D3, and n-3 fatty acids', 'type': 'OTHER', 'otherNames': ['probiotics, vitamin D-3, and n-3 fatty acids'], 'description': 'Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and n-3 fatty acids, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.', 'armGroupLabels': ['Juice containing probiotics, vitamin D3, and n-3 PUFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11855', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Agricultural University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Emilia Papakonstantinou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Agricultural University of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agricultural University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Aimilia Papakonstantinou', 'investigatorAffiliation': 'Agricultural University of Athens'}}}}