Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06632002
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2024-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2024-10-06', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Energy, macronutrient and micronutrient intakes', 'timeFrame': 'Study Days 45 and 90', 'description': 'A 3-day Dietary Record (two weekdays and one weekend day) will be completed by participant for the week prior Study Day 45 and 90 and evaluated by a dietitian. Nutrient analysis will be performed using a dietary analysis program.'}, {'measure': 'Energy, macronutrient and micronutrient adequacy', 'timeFrame': 'Study Days 45 and 90', 'description': 'Nutrient adequacy will be determined by comparing nutrient intakes (outcome No. 21) against sex- and age- specific local recommended nutrient intakes (RNI).'}, {'measure': 'Product intake compliance', 'timeFrame': 'Study Days 90', 'description': 'Compliance to study product prescribed over 90-day intervention period'}, {'measure': 'Adverse events', 'timeFrame': 'Study Day 1 to Day 90', 'description': 'Reported adverse events for assessment of safety and tolerability'}], 'primaryOutcomes': [{'measure': 'Serum albumin', 'timeFrame': 'Study Day 1 to Day 90', 'description': 'Change in serum albumin levels from baseline to Day 90'}], 'secondaryOutcomes': [{'measure': 'Serum albumin', 'timeFrame': 'Study Days 45 and 90', 'description': 'Serum albumin levels'}, {'measure': 'Malnutrition risk', 'timeFrame': 'Study Days 45 and 90', 'description': 'Mini Nutritional Assessment - Short Form (MNA®-SF) a validated screening tool for identifying elderly persons who are at risk for malnutrition, or who are already malnourished. It classifies participants into one of three categories:\n\n1. Normal nutritional status/score =12 to 14 points,\n2. At risk of malnutrition/score = 8 to 11 points,\n3. Malnourished/score = 0 to 7 points. Minimum point = 0, Maximum points = 14. Lower score indicates worse outcome, i.e., at risk of malnutrition or malnourished.'}, {'measure': 'Malnutrition risk', 'timeFrame': 'Study Days 45 and 90', 'description': 'Malnutrition Universal Screening Tool (MUST) is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories:\n\n1. Low risk/score = 0,\n2. Medium risk/score = 1,\n3. High risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.'}, {'measure': 'Serum prealbumin', 'timeFrame': 'Study Days 45 and 90', 'description': 'Serum prealbumin levels'}, {'measure': 'Body weight', 'timeFrame': 'Study Days 45 and 90', 'description': 'Body weight measured in kg'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Study Days 45 and 90', 'description': 'Calculated as weight (kg)/height (m)2'}, {'measure': 'Mid arm circumference', 'timeFrame': 'Study Days 45 and 90', 'description': 'Mid arm circumference measured in cm'}, {'measure': 'Mid arm muscle circumference', 'timeFrame': 'Study Days 45 and 90', 'description': 'Mid arm muscle circumference measured in cm'}, {'measure': 'Triceps skinfold thickness', 'timeFrame': 'Study Days 45 and 90', 'description': 'Triceps skinfold thickness measured in mm'}, {'measure': 'Calf circumference', 'timeFrame': 'Study Days 45 and 90', 'description': 'Calf circumference measured in cm'}, {'measure': 'Waist circumference', 'timeFrame': 'Study Days 45 and 90', 'description': 'Waist circumference measured in cm'}, {'measure': 'Hip circumference', 'timeFrame': 'Study Days 45 and 90', 'description': 'Hip circumference measured in cm'}, {'measure': 'Waist-to-hip-ratio', 'timeFrame': 'Study Days 45 and 90', 'description': 'Waist-to-hip-ratio'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'Study Days 45 and 90', 'description': 'HbA1c levels'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'Study Days 45 and 90', 'description': 'Fasting plasma glucose levels'}, {'measure': '2-hour postprandial glucose', 'timeFrame': 'Study Days 45 and 90', 'description': '2-hour postprandial glucose levels'}, {'measure': 'Glycated albumin', 'timeFrame': 'Study Days 45 and 90', 'description': 'Glycated albumin levels'}, {'measure': 'Triglycerides', 'timeFrame': 'Study Days 45 and 90', 'description': 'Triglycerides levels'}, {'measure': 'High density lipoprotein (HDL) cholesterol', 'timeFrame': 'Study Days 45 and 90', 'description': 'HDL cholesterol levels'}, {'measure': 'Low density lipoprotein (LDL) cholesterol', 'timeFrame': 'Study Days 45 and 90', 'description': 'LDL cholesterol levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk.', 'detailedDescription': 'This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Has any of the following types of diabetes:\n\n 1. Type 1 diabetes\n 2. Type 2 diabetes\n 3. Prediabetes\n2. Has MNA-SF score of ≤ 11\n3. Serum albumin less than 4.0 g/dL\n4. Energy or protein intake less than recommended\n5. BMI less than 30.0 kg/m2\n6. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study\n7. Female of childbearing potential to use an effective method of birth control\n8. Chronic medication type and dose to be constant and maintained throughout the study\n9. Willing to follow the protocol throughout the study\n10. At least a two-week washout period between the completion of a previous research study and start in current study\n11. Willing to refrain from taking non-study diabetes-specific formula over the course of the study.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has a screening HbA1c level less than 5.0% or ≥ 10%\n2. Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks\n3. Has active malignancy within the last 5 years\n4. Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure\n5. Has end-stage organ failure or is post-organ transplant\n6. Has current or history of renal disease or on dialysis or severe gastroparesis\n7. Has current hepatic disease\n8. Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study\n9. Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product\n10. Has a chronic, contagious, infectious disease\n11. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study procedures\n12. Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study\n13. Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months\n14. Has clotting or bleeding disorders\n15. Has blood or blood-related diseases\n16. Has received blood transfusion within the last 3 weeks\n17. Has allergy or intolerance to the study product\n18. Anticipated poor compliance to the study as assessed by the Investigator\n19. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition'}, 'identificationModule': {'nctId': 'NCT06632002', 'briefTitle': 'Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'A Randomized, Double-blind, Non-inferiority Trial of a New Diabetes-specific Formula Compared to an Existing Diabetes-specific Formula on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support', 'orgStudyIdInfo': {'id': 'BL80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Product', 'interventionNames': ['Other: DSF1', 'Other: Standard of Care (SOC)']}, {'type': 'OTHER', 'label': 'Control Product', 'interventionNames': ['Other: DSF2', 'Other: Standard of Care (SOC)']}], 'interventions': [{'name': 'DSF1', 'type': 'OTHER', 'description': '220 mL', 'armGroupLabels': ['Experimental Product']}, {'name': 'DSF2', 'type': 'OTHER', 'description': '220 mL', 'armGroupLabels': ['Control Product']}, {'name': 'Standard of Care (SOC)', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Control Product', 'Experimental Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Mei Qi Mak, BSc', 'role': 'CONTACT', 'email': 'meiqi.mak@abbott.com', 'phone': '+65 68016272'}], 'overallOfficials': [{'name': 'Mandy Yen Ling Ow, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}