Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 11:19 AM
Study NCT ID:
NCT04293003
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2020-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Morning 16/8 Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'C407088', 'term': 'Angptl4 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobilisation of adipose tissue', 'timeFrame': '6 hours', 'description': 'Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration'}], 'secondaryOutcomes': [{'measure': 'Mobilisation of gut peptides', 'timeFrame': '6 hours', 'description': 'AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration'}, {'measure': 'Degree of appetite suppression', 'timeFrame': '6 hours', 'description': 'Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite'}, {'measure': 'Degree of satiety induction', 'timeFrame': '6 hours', 'description': 'Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.', 'detailedDescription': 'The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.\n\nAt zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.\n\nBlood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-25 kg/m2\n* Willfulness to participate\n\nExclusion Criteria:\n\n* Overweight or obesity (BMI\\>25 kg/m2)\n* Type 1 or 2 diabetes mellitus\n* Uncontrolled thyroid disorders'}, 'identificationModule': {'nctId': 'NCT04293003', 'briefTitle': 'Metabolic Effects of Morning 16/8 Fasting', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies', 'orgStudyIdInfo': {'id': '39/12-02-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting', 'description': '6-hour morning fasting', 'interventionNames': ['Other: fasting']}, {'type': 'EXPERIMENTAL', 'label': 'Low carbohydrate', 'description': 'Consumption of a zero-carbohydrate breakfast', 'interventionNames': ['Other: Low carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean', 'description': 'Consumption of a Mediterranean breakfast', 'interventionNames': ['Other: Mediterranean']}], 'interventions': [{'name': 'fasting', 'type': 'OTHER', 'description': '6-hour fasting', 'armGroupLabels': ['Fasting']}, {'name': 'Low carbohydrate', 'type': 'OTHER', 'description': 'Consumption of a zero-carbohydrate breakfast', 'armGroupLabels': ['Low carbohydrate']}, {'name': 'Mediterranean', 'type': 'OTHER', 'description': 'Consumption of a Mediterranean-type breakfast', 'armGroupLabels': ['Mediterranean']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Internal Medicine', 'investigatorFullName': 'Alexandros Kokkinos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}