Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-19 @ 7:57 AM
Study NCT ID:
NCT02651051
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], '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'}]}}, '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': '2016-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-08', '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 fat content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.', 'detailedDescription': "Participants will be asked to report to the lab for their first main trial, having not eaten for 12 hours, and refrained from caffeine and alcohol intake and strenuous exercise for 24 hours. Both trials will take place at the same time of day.\n\nUpon arrival height and body mass will be recorded and a cannula will be inserted into a vein in the back of the hand and a 10 ml blood sample will be taken.A visual analogue scale (VAS) will then be used to subjectively measure the participant's appetite pre-breakfast.\n\nParticipants will then be provided with one of the two breakfast meals that are being tested in a randomised order. The two breakfasts consist of a high fat breakfast or high fat plus additional whey protein. A drink of water shall also be consumed, the volume of which depends on the trial being carried out. The high fat breakfast will consist of scrambled egg yolks made with single cream and butter (Tesco, Hertfordshire, UK). The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total). For the whey protein trial, 23.9g whey protein isolate (Lacprodan DI-9224, Arla Foods, Denmark) shall be added to water and incorporated into each meal as a drink on the side, in order to provide 20g whey protein.\n\nA timer shall be set when the participant takes their first mouthful of breakfast, and they will be required to rest for the following 3 hours. At 15, 30, 45, 60, 90, 120, 150 and 180 minutes post-breakfast 10 ml blood samples shall be collected. Every 30 minutes during this period the appetite VAS will also be completed. After this participants will be provided with a standardised lunch meal which shall consist of pasta with a tomato and basil sauce, olive oil and cheddar cheese, along with a 350 ml drink of water. The macronutrient distribution of the lunch is 13% protein, 49% carbohydrate, 38% fat. Following this, the post-breakfast procedure shall be repeated for another period of 3 hours."}, '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': 'NCT02651051', 'briefTitle': 'Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Influence of Whey Protein Addition to a Fat-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal', 'orgStudyIdInfo': {'id': 'HLS-13-131017b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'High Fat Breakfast Meal', 'description': 'High fat breakfast meal served without addition of whey protein isolate', 'interventionNames': ['Other: High Fat Breakfast Meal']}, {'type': 'EXPERIMENTAL', 'label': 'High Fat Breakfast Meal + Whey Protein', 'description': 'High fat breakfast meal served with addition of whey protein isolate', 'interventionNames': ['Dietary Supplement: Whey Protein', 'Other: High Fat Breakfast Meal']}], 'interventions': [{'name': 'Whey Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal', 'armGroupLabels': ['High Fat Breakfast Meal + Whey Protein']}, {'name': 'High Fat Breakfast Meal', 'type': 'OTHER', 'description': 'A standardised high fat breakfast served to all participants. The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total)', 'armGroupLabels': ['High Fat Breakfast Meal', 'High Fat Breakfast Meal + 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'}}}}