Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-02 @ 10:30 AM
Study NCT ID:
NCT02440932
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010661', 'term': 'Phenylketonurias'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-20', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appetite hormone: peptide YY (PYY)', 'timeFrame': '300 minutes', 'description': 'Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)'}, {'measure': 'Appetite hormone: glucagon-like peptide-1 (GLP-1)', 'timeFrame': '300 minutes', 'description': 'Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)'}, {'measure': 'Appetite hormone: cholecystokinin (CCK)', 'timeFrame': '300 minutes', 'description': 'Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)'}, {'measure': 'Appetite hormone: insulin', 'timeFrame': '300 minutes', 'description': 'Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)'}, {'measure': 'Appetite hormone: ghrelin', 'timeFrame': '300 minutes', 'description': 'Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)'}, {'measure': 'Subjective appetite score', 'timeFrame': '300 minutes', 'description': 'Visual analogue scale (VAS) collected at baseline and after each blood sample collection'}, {'measure': 'Diet induced thermogenesis', 'timeFrame': '300 minutes', 'description': 'Metabolic rate by means of computerised open-circuit ventilated hood system collected at baseline and after each blood sample collection for the duration of 20 minutes'}], 'secondaryOutcomes': [{'measure': 'Taste perception of PKU supplements/foods', 'timeFrame': '10 minutes', 'description': 'Immediately after supplement ingestion and lunch consumption'}, {'measure': 'Consumption time for PKU supplements/foods', 'timeFrame': '20 minutes', 'description': 'Maximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low Phenylalanine diet', 'PKU supplements', 'diet induced thermogenesis', 'appetite', 'body weight'], 'conditions': ['Phenylketonuria (PKU)']}, 'referencesModule': {'references': [{'pmid': '28318688', 'type': 'DERIVED', 'citation': 'Alfheeaid H, Gerasimidis K, Nastase AM, Elhauge M, Cochrane B, Malkova D. Impact of phenylketonuria type meal on appetite, thermic effect of feeding and postprandial fat oxidation. Clin Nutr. 2018 Jun;37(3):851-857. doi: 10.1016/j.clnu.2017.03.005. Epub 2017 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus, low-phenylalanine diets help patients to manage their condition but it is not clear whether they have an impact on appetite, energy intake and changes in body weight. This is important to explore as prevalence of obesity in this population is rising high. This study aims to find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy expenditure. The investigators will recruit 26 healthy adults and ask them to participate in two experimental trials. On one occasion the participants will be asked to consume a PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement and lunch will be based on normally consumed foods. Series of blood samples will be taken and appetite will be assessed during both experiments. Both experimental trials will finish with consuming an "all-you-can-eat" buffet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult\n2. Body weight stable for previous 4 months\n3. Regular menstrual cycle (females)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation (females)\n2. History of eating disorder\n3. History of gastrointestinal problems or surgery\n4. History of allergy\n5. History of chronic illness\n6. On any medication\n7. Smoking\n8. On nutritional supplements\n9. Following specific diet\n10. Currently taking part in other research'}, 'identificationModule': {'nctId': 'NCT02440932', 'briefTitle': 'Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis', 'orgStudyIdInfo': {'id': '200130139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenylketonuria-type diet', 'description': 'Breakfast: one pouch of amino acid supplement (174 mls supplemented drink PKU cooler 20, Vitaflo®; 20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich \\[low protein bread (Juvela, UK), no protein vegan cheese (Viotros, UK)\\], low protein crackers (Vitaflo, UK), and low protein cookies (Juvela, UK).\n\nDinner: ad libitum buffet meal', 'interventionNames': ['Dietary Supplement: Phenylketonuria-type diet', 'Other: Normal (control) diet']}, {'type': 'OTHER', 'label': 'Normal diet', 'description': 'Breakfast: 174 ml of milk (20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich, crackers, and cookies (regular foods) Dinner: ad libitum buffet meal', 'interventionNames': ['Dietary Supplement: Phenylketonuria-type diet', 'Other: Normal (control) diet']}], 'interventions': [{'name': 'Phenylketonuria-type diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast, lunch and open buffet dinner', 'armGroupLabels': ['Normal diet', 'Phenylketonuria-type diet']}, {'name': 'Normal (control) diet', 'type': 'OTHER', 'description': 'Breakfast, lunch and open buffet dinner', 'armGroupLabels': ['Normal diet', 'Phenylketonuria-type diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G31 2ER', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Human Nutrition, School of Medicine, University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Dalia Malkova, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Dr Dalia Malkova', 'investigatorAffiliation': 'University of Glasgow'}}}}