Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:29 AM
Study NCT ID:
NCT07466667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Effect of Phaseolean on Glycemic Response to Carbohydrate Rich Meal in Healthy Adult Human Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-07', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the glycemic response to carbohydrate rich meal (with high Glycemic Index)', 'timeFrame': 'At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29', 'description': 'When consumed with test products in healthy participants under in-vivo conditions.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)', 'timeFrame': 'At baseline and after 30, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29', 'description': 'By assessing change in satiety level (hunger, fullness \\& desire to eat) by using visual analogue scale based subjective questionnaire'}, {'measure': 'To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)', 'timeFrame': 'At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29', 'description': 'By assessing change in glycemic Load by standard calculation method.'}, {'measure': 'To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)', 'timeFrame': 'At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29', 'description': 'By assessing change in Calorie Index by standard calculation method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phaseolean', 'Glycemic Response', 'Anhydrous Glucose Powder'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an Open-Label, Randomized, Three-Way, Three-Arm, Crossover, Balance Study to Evaluate the Effect of Phaseolean on Glycemic response to carbohydrate rich meals in Healthy Adult Participants Using an In Vivo Method.', 'detailedDescription': "A total of 12 participants including male and non-pregnant/non-lactating females aged between 18-45 years will be enrolled in the study to complete evaluation of 10 participants for the study.\n\nIn accordance with guidance ISO 26642:2010, participants will be tested for test products once and reference food thrice in random order on separate days, with at least a 2 days washout period between measurements to minimize carry-over effects. The potential participants will be screened on the basis of inclusion and exclusion criteria only after obtaining written informed consent from the participants. Participants will be contacted telephonically by the recruiting department prior to the enrolment visit. The participants will be requested to bring any previous medications and relevant laboratory reports (if any) on the day of the study visit.\n\nUpon qualification for the study, participants will undergo in the glycemic index evaluation. Each qualified Participant will receive reference product thrice in random order on separate days, with at least a 2 days washout period. Following completion of the reference product phase, participants will receive the test product(s) as per the predefined randomization under a crossover design, with a washout period of seven (7) days. Participants will be asked to stay fasted overnight for 10-12 hours or more before ingesting reference product or test product. The participant will then rate the test product's satiety level in comparison with reference product. The participant will be evaluated for a final evaluation by the investigator at the end of the study.\n\nSafety will be assessed throughout the study by monitoring of adverse events.\n\nThe participants will be instructed to visit the facility as per the below visits:\n\n* Period 1 (Visit 1) Day 0: Screening, Enrolment phase, Overnight stay\n* Day 1: 1st time reference product consumption\n* Then Washout Period (2 Days)\n* Period 2 (Visit 2) Day 4: Admission and Overnight stay\n* Day 5: 2nd time reference product consumption\n* Then Washout Period (2 Days)\n* Period 3 (Visit 3) Day 8: Admission and Overnight stay\n* Day 9: 3rd time reference product consumption\n* Then Washout Period (2 Days)\n* Period 4 (Visit 4) Day 12: Admission and Overnight stay\n* Day 13: Test product consumption (per randomization)\n* Then Washout Period (7 Days) - Cross Over Design\n* Period 5 (Visit 5) Day 20: Admission and Overnight stay\n* Day 21: Test product consumption (per randomization)\n* Then Washout Period (7 Days) - Cross Over Design\n* Period 6 (Visit 6) Day 28: Admission and Overnight stay\n* Day 29: Test product consumption (per randomization)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1)Age: 18 to 45 years (both inclusive) at the time of consent Sex: male and non-pregnant/non-lactating female. 3) Females of childbearing potential must have a negative urine pregnancy test performed on screening visits.\n\n4\\) Participants having fasting blood glucose levels less than 100 milligrams per decilitre.\n\n5\\) Participants with a Body Mass Index of 18.5 to 25 kilogram per meter square (both inclusive).\n\n6\\) Participant is in good general health as determined by the Investigator on the basis of medical history and vital signs.\n\n7\\) Participants should be willing and able to follow the study protocol to participate in the study.\n\n8\\) Participant must be able to understand and provide written informed consent to participate in the study.\n\n9\\) Participant is willing to refrain from vigorous physical exercise during the study period.\n\n10\\) Participants is willing to stay overnight as per study specification requirements.\n\nExclusion Criteria:\n\n1. Participant has any known food allergy or intolerance to any food or beverages.\n2. Participant is taking any medication in the past one week.\n3. Participants should not be taking any medications known to affect glucose tolerance (excluding oral contraceptives) - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable\n4. Participants should not have any known food allergy or intolerance\n5. Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.\n6. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.\n7. Participation in any similar clinical trial within the past 90 days with blood loss more than 450 millilitre.\n8. An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout the Participant's participation in the study.\n9. Participant has performed vigorous physical exercise in the morning on dosing day.\n10. Pregnant or lactating females.\n11. Self-reported Positive Human Immunodeficiency Virus test.\n12. History of Hepatitis B or C virus self-reported"}, 'identificationModule': {'nctId': 'NCT07466667', 'acronym': 'PHEGI', 'briefTitle': 'To Determine the Effect of Phaseolean on Glycemic Response to Carbohydrate Rich Meal in Healthy Adult Human Participants', 'organization': {'class': 'OTHER', 'fullName': 'NovoBliss Research Pvt Ltd'}, 'officialTitle': 'An Open-Label, Randomized, Three-Way, Three-Arm, Crossover, Balance Study to Evaluate the Effect of Phaseolean on Healthy Glycemic Response to Carbohydrate- Rich Meals in Healthy Adult Participants Using an In Vivo Method', 'orgStudyIdInfo': {'id': 'NB260014-AP_1.0_24Feb26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plain white bread + 1000 milligrams Phaseolean', 'description': 'The test product(s) will be dissolved in 50-100 millilitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.\n\nRoute of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'interventionNames': ['Dietary Supplement: Phaseolean (White Kidney Bean Extract) 1000 milligrams']}, {'type': 'EXPERIMENTAL', 'label': 'Plain white bread + 2000 milligram Phaseolean', 'description': 'The test product(s) will be dissolved in 50-100 mililitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.\n\nRoute of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'interventionNames': ['Dietary Supplement: Phaseolean (White Kidney Bean Extract) 2000 milligrams']}, {'type': 'EXPERIMENTAL', 'label': 'Anhydrous Glucose Powder', 'description': 'Mode of Administration: 50 grams of anhydrous glucose powder will be dissolved in 250 millilitre of potable water Route of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'interventionNames': ['Other: Anhydrous Glucose Powder']}, {'type': 'EXPERIMENTAL', 'label': 'Plain white bread', 'description': 'Participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.', 'interventionNames': ['Other: Plain white bread']}], 'interventions': [{'name': 'Phaseolean (White Kidney Bean Extract) 1000 milligrams', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The test product(s) will be dissolved in 50-100 millilitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitres of tea or coffee with milk sweetened using a non-nutritive sweetener.\n\nRoute of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'armGroupLabels': ['Plain white bread + 1000 milligrams Phaseolean']}, {'name': 'Phaseolean (White Kidney Bean Extract) 2000 milligrams', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The test product(s) will be dissolved in 50-100 millilitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.\n\nRoute of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'armGroupLabels': ['Plain white bread + 2000 milligram Phaseolean']}, {'name': 'Anhydrous Glucose Powder', 'type': 'OTHER', 'description': 'Mode of Administration: 50 grams of anhydrous glucose powder will be dissolved in 250 millilitre of potable water Route of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)', 'armGroupLabels': ['Anhydrous Glucose Powder']}, {'name': 'Plain white bread', 'type': 'OTHER', 'description': 'Participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.', 'armGroupLabels': ['Plain white bread']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maheshvari Patel', 'role': 'CONTACT', 'email': 'maheshvari@novobliss.in', 'phone': '+91 9909013236'}, {'name': 'Sheetal Khandwala', 'role': 'CONTACT', 'email': 'bd@novobliss.in'}], 'overallOfficials': [{'name': 'Nayan Patel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NovoBliss Research Pvt Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovoBliss Research Pvt Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ambe Phytoextracts Pvt. Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}