Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT03361566
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2017-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D002149', 'term': 'Energy Intake'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004032', 'term': 'Diet'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy balance', 'timeFrame': '24 hours', 'description': 'difference between predefined energy balance and measured energy balance'}], 'secondaryOutcomes': [{'measure': 'ghrelin levels', 'timeFrame': 'every 2 hours during the day over 14 hours', 'description': 'area under the curve of total plasma ghrelin'}, {'measure': 'arterial stiffness', 'timeFrame': '15 hours', 'description': 'pulse wave velocity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'energy balance', 'caloric restriction', 'overfeeding', 'appetite regulation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31305927', 'type': 'DERIVED', 'citation': 'Hagele FA, Busing F, Nas A, Hasler M, Muller MJ, Blundell JE, Bosy-Westphal A. Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4481-4491. doi: 10.1210/jc.2019-01164.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to investigate the impact of energy flux (achieved by changes in physical activity) under the conditions of energy balance, caloric restriction and overfeeding in healthy subjects.', 'detailedDescription': 'A low energy flux is achieved by low energy expenditure, equivalent to low physical activity and with a corresponding low energy intake. A high energy flux is achieved by high energy expenditure, equivalent to high physical activity and with a corresponding high energy intake, respectively.\n\nThe protocol of this randomized, intra-individual nutrition intervention includes 12 one-day interventions with 3 different levels of energy flux and 4 different diet conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 years of age\n* healthy\n* BMI between 18.5 and 31 kg/m2\n\nExclusion Criteria:\n\n* smoking\n* food allergies\n* alternative nutrition habits like vegetarian / vegan\n* chronic diseases\n* regular medication intake\n* claustrophobia\n* weight loss \\> 5 kg in the last 3 years'}, 'identificationModule': {'nctId': 'NCT03361566', 'acronym': 'EF', 'briefTitle': 'Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz', 'orgStudyIdInfo': {'id': 'EF2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low energy flux at ad libitum energy intake', 'description': 'physical activity: inactive energy intake: ad libitum', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'medium energy flux at ad libitum energy intake', 'description': 'physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'high energy flux at ad libitum energy intake', 'description': 'physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'Low energy flux at energy balance', 'description': 'physical activity: inactive energy intake: individual energy balance', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'medium energy flux at energy balance', 'description': 'physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'high energy flux at energy balance', 'description': 'physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'low energy flux at caloric restriction', 'description': 'physical activity: inactive energy intake: caloric restriction -25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'medium energy flux at caloric restriction', 'description': 'physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'high energy flux at caloric restriction', 'description': 'physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'low energy flux at overfeeding', 'description': 'physical activity: inactive energy intake: overfeeding +25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'medium energy flux at overfeeding', 'description': 'physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}, {'type': 'EXPERIMENTAL', 'label': 'high energy flux at overfeeding', 'description': 'physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25%', 'interventionNames': ['Behavioral: physical activity', 'Behavioral: energy intake']}], 'interventions': [{'name': 'physical activity', 'type': 'BEHAVIORAL', 'description': '3 different levels of physical activity', 'armGroupLabels': ['Low energy flux at energy balance', 'high energy flux at ad libitum energy intake', 'high energy flux at caloric restriction', 'high energy flux at energy balance', 'high energy flux at overfeeding', 'low energy flux at ad libitum energy intake', 'low energy flux at caloric restriction', 'low energy flux at overfeeding', 'medium energy flux at ad libitum energy intake', 'medium energy flux at caloric restriction', 'medium energy flux at energy balance', 'medium energy flux at overfeeding']}, {'name': 'energy intake', 'type': 'BEHAVIORAL', 'description': '4 different types of energy intake', 'armGroupLabels': ['Low energy flux at energy balance', 'high energy flux at ad libitum energy intake', 'high energy flux at caloric restriction', 'high energy flux at energy balance', 'high energy flux at overfeeding', 'low energy flux at ad libitum energy intake', 'low energy flux at caloric restriction', 'low energy flux at overfeeding', 'medium energy flux at ad libitum energy intake', 'medium energy flux at caloric restriction', 'medium energy flux at energy balance', 'medium energy flux at overfeeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Institute of Nutritional Medicine, University of Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Anja Bosy-Westphal, Prof PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hohenheim, Stuttgart, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}