Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04518605
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2020-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breakfast for Young Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in physical activity', 'timeFrame': '12 weeks', 'description': 'by accelerometry'}, {'measure': 'Changes in dietary intake', 'timeFrame': '12 weeks', 'description': 'by 4-day dietary registration'}, {'measure': 'Changes in calcium and supplement intake', 'timeFrame': '12 weeks', 'description': 'by a standard, validated food frequency questionnaire.'}, {'measure': 'Change in gut microflora', 'timeFrame': '12 weeks', 'description': 'by bacterial determination of faeces'}, {'measure': 'Changes in faeces pH', 'timeFrame': '12 weeks', 'description': 'by pH determination of faeces'}, {'measure': 'Changes in urine metabolites', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine samples will be collected to perform a metabolomics analysis by mass spectroscopy.'}, {'measure': 'Changes in faeces metabolites', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the intervention on the metabolism through a metabolomic approach. Faeces samples will be collected to perform a metabolomics analysis by mass spectroscopy.'}, {'measure': 'Changes in blood metabolites', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the intervention on metabolism through a metabolomic approach. Blood samples will be collected to perform a metabolomics analysis by mass spectroscopy.'}], 'primaryOutcomes': [{'measure': 'Change in Fat mass in grams', 'timeFrame': '12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Change in Fat free mass in grams', 'timeFrame': '12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Change in Lean body mass in grams', 'timeFrame': '12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Change in Height (cm)', 'timeFrame': '12 weeks', 'description': 'by stadiometer'}, {'measure': 'Change in weight (kg)', 'timeFrame': '12 weeks', 'description': 'Tanita Scale'}, {'measure': 'Change in BMI (m^2/kg)', 'timeFrame': '12 weeks', 'description': 'Measured by height in meters and weight in kg'}, {'measure': 'Change in Waist circumference (cm)', 'timeFrame': '12 weeks', 'description': 'by tape'}, {'measure': 'Change in HbA1c', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in high density lipoprotein cholesterol (HDL cholesterol)', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in low density lipoprotein cholesterol (LDL cholesterol)', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in triacylglycerol (TG)', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in total cholesterol', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in glucose', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in insulin', 'timeFrame': '12 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Change in glucose tolerance (area under the curve)', 'timeFrame': '12 weeks', 'description': 'measured by a two hour oral glucose tolerance test'}, {'measure': 'Change in glucose peak', 'timeFrame': '12 weeks', 'description': 'measured by a two hour oral glucose tolerance test'}, {'measure': 'Change in fitness (estimated VO2-max)', 'timeFrame': '12 weeks', 'description': 'Measured by Åstrand two-step bike test'}, {'measure': 'Change in maximal hand grip strength', 'timeFrame': '12 weeks', 'description': 'Measured by hand held dynamometer'}, {'measure': 'Change in maximal arm strength', 'timeFrame': '12 weeks', 'description': 'Measured by costummade dynamometer'}, {'measure': 'Change in maximal jump height', 'timeFrame': '12 weeks', 'description': 'Measured by squat jump with linear encoder'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '12 weeks', 'description': 'by standard blood pressure apparatus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dairy protein', 'Breakfast content', 'body composition', 'Muscle strength', 'Gut microbiota/microflora', 'Dietary recommendations', 'Exercise training'], 'conditions': ['Overweight and Obesity', 'Overweight Adolescents', 'Metabolic Disease']}, 'referencesModule': {'references': [{'pmid': '39587799', 'type': 'DERIVED', 'citation': 'Dalgaard LB, Thams L, Skovgaard Jensen J, Jorgensen AA, Breenfeldt Andersen A, Gejl KD, Bertram HC, Hansen M. No effects of high- v. low-protein breakfast on body composition and cardiometabolic health in young women with overweight: the NewStart randomised trial. Br J Nutr. 2025 Jan 14;133(1):126-135. doi: 10.1017/S0007114524003015. Epub 2024 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.', 'detailedDescription': 'The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period.\n\nThe primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\> 25\n* Regular exercise \\< 1 hour per week\n\nExclusion Criteria:\n\n* illness and use of medication affecting the study outcomes\n* allergy towards milk and yoghurt\n* weightloss/gain \\>5kg the last 6 months\n* dieting\n* eating disorder\n* pregnancy\n* breast feeding\n* unable to speak and understand danish'}, 'identificationModule': {'nctId': 'NCT04518605', 'acronym': 'NyStart2', 'briefTitle': 'Breakfast for Young Females', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Breakfast for Young Females - the Importance of Breakfast Type', 'orgStudyIdInfo': {'id': 'NyStart2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low protein breakfast', 'description': 'Subject will eat a low protein breakfast and maintain their habitual physical activity.', 'interventionNames': ['Dietary Supplement: Low protein breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'High protein breakfast', 'description': 'Subject will eat a high protein breakfast and maintain their habitual physical activity.', 'interventionNames': ['Dietary Supplement: High protein breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Low protein breakfast and exercise training', 'description': 'Subject will consume a low protein breakfast (bread, jam, juice) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)', 'interventionNames': ['Dietary Supplement: Low protein breakfast', 'Other: Exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'High protein breakfast and exercise training', 'description': 'Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr) with oats) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)', 'interventionNames': ['Dietary Supplement: High protein breakfast', 'Other: Exercise training']}], 'interventions': [{'name': 'Low protein breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume \\~60 g bread, 20 g jam and 250 ml juice for breakfast.', 'armGroupLabels': ['Low protein breakfast', 'Low protein breakfast and exercise training']}, {'name': 'High protein breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast.', 'armGroupLabels': ['High protein breakfast', 'High protein breakfast and exercise training']}, {'name': 'Exercise training', 'type': 'OTHER', 'description': 'Participants will be asked to participate in organized exercise training 3 times per week.', 'armGroupLabels': ['High protein breakfast and exercise training', 'Low protein breakfast and exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University, Department for Public Health, Section for Sport Science', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Mette Hansen, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Dairy Research Foundation, Denmark', 'class': 'OTHER'}, {'name': 'Sygekassernes Helsefond', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}