Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03135132
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mild Weight Loss on Circulating Metabolite Profiles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visceral fat area at L4 (CT)', 'timeFrame': 'At baseline'}, {'measure': 'Visceral fat area at L4 (CT)', 'timeFrame': 'At 12-week follow-up'}, {'measure': 'Change in visceral fat area at L4 from baseline', 'timeFrame': 'At baseline and 12-week follow-up'}, {'measure': 'Putatively identified plasma metabolites (Normalized peak intensities)', 'timeFrame': 'At baseline'}, {'measure': 'Putatively identified plasma metabolites (Normalized peak intensities)', 'timeFrame': 'At 12-week follow-up'}, {'measure': 'Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline', 'timeFrame': 'At baseline and 12-week follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High visceral fat', 'Low calorie diet', 'Mild weight loss', 'Metabolomics', 'Metabolites', 'Acylcarnitines'], 'conditions': ['Visceral Fat', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '34099056', 'type': 'DERIVED', 'citation': 'Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.'}, {'pmid': '30322392', 'type': 'DERIVED', 'citation': 'Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.', 'detailedDescription': 'Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent\n* 20-65 years old\n* Males and females\n* Overweight (25.0 kg/m²≤ Body mass index \\<30 kg/m²)\n* Nondiabetic (Fasting glucose \\<126 mg/dL)\n\nExclusion Criteria:\n\n* Unstable body weight (body weight change \\>1 kg within 3 months before screening)\n* Consumption of medication that affects body weight or energy expenditure\n* Pregnancy or breast-feeding\n* Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease\n* Liver disease, kidney disease, or gastrointestinal disease\n* Acute or chronic infections\n* Any acute or chronic disease requiring treatment'}, 'identificationModule': {'nctId': 'NCT03135132', 'briefTitle': 'The Effect of Mild Weight Loss on Circulating Metabolite Profiles', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss', 'orgStudyIdInfo': {'id': 'Wt loss_metabolites'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Usual dietary intake group', 'interventionNames': ['Behavioral: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'LCD group', 'description': 'Low calorie diet (LCD) group (300kcal/day intake reduction)', 'interventionNames': ['Behavioral: LCD group']}], 'interventions': [{'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Recommend to consume usual diet during 12-week study period', 'armGroupLabels': ['Control group']}, {'name': 'LCD group', 'type': 'BEHAVIORAL', 'description': 'Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day', 'armGroupLabels': ['LCD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Ho Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}