Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT06856460
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose response between two breakfasts', 'timeFrame': 'the entire 2 hours of the glycemic test', 'description': 'The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion.'}, {'measure': 'Insulin responses between the two breakfasts', 'timeFrame': 'The entire 2 hours period', 'description': 'The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion.'}, {'measure': 'Glucose réponses during glucose challenge test', 'timeFrame': '2 hours post ingestion of the emperimental meal (cereal or ceral + shake)', 'description': 'Positive integer of the area under the curve for glucose during the 2 hours glycemic test'}, {'measure': 'Insulin responses during the glucemic challenge test', 'timeFrame': '2 hour post ingestion of the intervention meal (cereal or cereal + shake)', 'description': 'Positive integer of the area under the curve for insulin during the 2-hours glycemic test'}], 'secondaryOutcomes': [{'measure': 'Ambulatory glucose profile', 'timeFrame': 'total area under the curve during the 2 weeks (14 days) of dietary intervention.', 'description': 'The difference between the two groups on the area under the curve in Ambulatory glucose measured with a continuous glucose monitor during the 2 weeks of dietary intervention.'}, {'measure': 'Blood glucagon', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood glucagon difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}, {'measure': 'Glucagon like peptide 1', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood Glucagon like peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}, {'measure': 'Leptin', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood Leptin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}, {'measure': 'Adiponectin', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood Adiponectin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}, {'measure': 'Ghrelin', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood Ghrelin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}, {'measure': 'C-Peptide', 'timeFrame': '0, 30, 60, 90, and 120 minutes of the glycemic test.', 'description': 'Blood c-peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meal replacement', 'glucose regulation'], 'conditions': ['Hyperglycemia', 'Obesity Prevention']}, 'descriptionModule': {'briefSummary': 'Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets.\n\nThe present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults.\n\nSubjects:\n\n40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 .\n\nProtocol:\n\nThis is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 25-40\n* Eating pattern 3 meals a day\n* stable weight for the last 2 months (\\<5 pounds fluctuation)\n* Willing to eat oat cereal for breakfast\n* glycated hemoglobin \\<7%\n\nExclusion Criteria:\n\n* glycated hemoglobin \\>7%\n* Body mass index ≤25 or ≥ 40\n* Night shifting work\n* Atypical meal pattern (not three meals a day or intermittent fasting)\n* Thyroid medication\n* Bariatric surgery\n* Habitual strenuous exercise\n* Commuting by bicycle\n* Eating disorders\n* Use of aspirin during the duration of the study\n* Intake of Vit C \\>60 mg/day during the study\n* cancer\n* cardiovascular disease\n* renal disease\n* hepatic disease\n* X-ray, MRI or CT appointment during the study duration\n* Current infection requiring medication\n* Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV\n* Medications of supplements that could affect body weight or appetite (i.e. Ozempic)\n* Participating in another study at the same time'}, 'identificationModule': {'nctId': 'NCT06856460', 'acronym': 'SHAKE', 'briefTitle': 'The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults', 'orgStudyIdInfo': {'id': 'STUDY00016899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control: Breakfast with 400 kcal of oat cereal with honey', 'interventionNames': ['Dietary Supplement: Ceral Breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake.', 'interventionNames': ['Dietary Supplement: powder shake with very low glycemic index']}], 'interventions': [{'name': 'powder shake with very low glycemic index', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged.', 'armGroupLabels': ['Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake.']}, {'name': 'Ceral Breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume of 400kcal of oat-based cereal with honey for breakfast', 'armGroupLabels': ['Control: Breakfast with 400 kcal of oat cereal with honey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arizona State University 850 PBC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'centralContacts': [{'name': 'Alicia Nguyen', 'role': 'CONTACT', 'email': 'shake.hydration@gmail.com', 'phone': '480-447-4811'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Assistant Dean', 'investigatorFullName': 'Stavros Kavouras', 'investigatorAffiliation': 'Arizona State University'}}}}