Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-03-16 @ 3:05 AM
Study NCT ID:
NCT02414061
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2015-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D062408', 'term': 'Breakfast'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D062407', 'term': 'Meals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial blood glucose responses', 'timeFrame': '0-360 minutes post breakfast', 'description': 'Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch'}], 'secondaryOutcomes': [{'measure': 'Acute subjective appetite responses', 'timeFrame': '0-360 minutes post breakfast', 'description': 'Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postprandial glycemia', 'metabolic health measures'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-40 years old (male)\n* Recreationally active (\\>30 minutes of structured exercise, 5 times/week)\n\nExclusion Criteria:\n\n* Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)\n* Taking any prescribed medication\n* Regular breakfast skipper\n* Food allergies or intolerances\n* Eating disorders\n* Smoker'}, 'identificationModule': {'nctId': 'NCT02414061', 'briefTitle': 'Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Influence of Whey Protein Addition to a Carbohydrate-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal', 'orgStudyIdInfo': {'id': 'HLS-13-131017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breakfast - Carbohydrate + Whey Protein', 'description': 'Addition of whey protein isolate (20 g dissolved in flavoured water) to breakfast meal composition', 'interventionNames': ['Dietary Supplement: Whey Protein (Arla Foods Ingredients Group)', 'Other: Breakfast meal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Breakfast - Carbohydrate', 'description': 'Only flavoured water consumed with breakfast meal', 'interventionNames': ['Other: Breakfast meal']}, {'type': 'NO_INTERVENTION', 'label': 'No Breakfast', 'description': 'Only water consumed at breakfast time point'}], 'interventions': [{'name': 'Whey Protein (Arla Foods Ingredients Group)', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 g whey protein isolate added to breakfast meal', 'armGroupLabels': ['Breakfast - Carbohydrate + Whey Protein']}, {'name': 'Breakfast meal', 'type': 'OTHER', 'description': 'Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)', 'armGroupLabels': ['Breakfast - Carbohydrate', 'Breakfast - Carbohydrate + Whey Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Faculty of Health and Life Sciences, Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Emma J Stevenson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}