Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-22 @ 7:30 PM
Study NCT ID:
NCT02471092
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)', 'timeFrame': '0-200 minutes'}], 'primaryOutcomes': [{'measure': 'Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)', 'timeFrame': '0-200 minutes'}], 'secondaryOutcomes': [{'measure': 'Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)', 'timeFrame': '0-200 minutes'}, {'measure': 'Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)', 'timeFrame': 'at 120 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['satiety', 'glycemia', 'milk protein'], 'conditions': ['Hyperglycemia', 'Lack of Satiety']}, 'referencesModule': {'references': [{'pmid': '33024990', 'type': 'DERIVED', 'citation': 'Kung B, Turgeon SL, Vien S, Kubant R, El Khoury D, Wright AJ, Goff HD, Anderson GH. Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio. J Nutr. 2020 Dec 10;150(12):3103-3113. doi: 10.1093/jn/nxaa275.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.', 'detailedDescription': '1. A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.\n2. Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 20 - 24.9 kg/m2\n* Healthy as determined by screening questionnaire\n* Male or Female\n* Non-smoking\n* Normal fasting plasma glucose (\\<5.5 mmol/L), but not below 3.3 mmol/L.\n* Prior use of acetaminophen\n\nExclusion Criteria:\n\n* Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)\n* Weight loss or weight gain of more than 5 kg during the previous 2 months\n* Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)\n* Serious medical condition (ie. Renal, liver)\n* Lack of appetite or skipping breakfast\n* Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint \\>16\n* Smoking\n* Reported intolerance to milk or very low consumption (\\< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.\n* Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise\n* Diabetes or other metabolic diseases that could interfere with study outcomes\n* Acetaminophen, codeine or opioid allergy\n* Pregnant or Breast Feeding\n* Typical alcohol consumption of not more than 4 drinks per sitting"}, 'identificationModule': {'nctId': 'NCT02471092', 'briefTitle': 'The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood', 'orgStudyIdInfo': {'id': '14JN004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water Control', 'description': 'Skim milk products. Water and permeate control; 250mL serving.', 'interventionNames': ['Other: Skim milk products']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Skim Milk', 'description': 'Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.', 'interventionNames': ['Other: Skim milk products']}, {'type': 'EXPERIMENTAL', 'label': 'High Protein Milk', 'description': 'Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.', 'interventionNames': ['Other: Skim milk products']}, {'type': 'EXPERIMENTAL', 'label': 'High Protein Milk (Modified Ratio)', 'description': 'Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.', 'interventionNames': ['Other: Skim milk products']}, {'type': 'EXPERIMENTAL', 'label': 'Skim Milk (Modified Ratio)', 'description': 'Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.', 'interventionNames': ['Other: Skim milk products']}], 'interventions': [{'name': 'Skim milk products', 'type': 'OTHER', 'description': 'Milk treatments will be served with 58g of breakfast cereal.', 'armGroupLabels': ['High Protein Milk', 'High Protein Milk (Modified Ratio)', 'Skim Milk', 'Skim Milk (Modified Ratio)', 'Water Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Guelph- Human Nutraceutical Research Unit', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Amanda J Wright, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Laval University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amanda Wright, Ph.D.', 'investigatorAffiliation': 'University of Guelph'}}}}