Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 6:14 PM
Study NCT ID:
NCT03483558
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vegetable Signature From Human Metabolomics Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensities of multiple serum metabolites', 'timeFrame': 'Baseline (fasting state before breakfast at 7:30AM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '4 Hours (immediately before lunch at 11:30AM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '5.5 hours (after lunch at 13:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '6.5 hours (after lunch at 14:00 PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '7.5 hours (after lunch at 15:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '8.5 hours (after lunch at 16:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '9.5 hours (after lunch at 17:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '10.5 hours (after lunch at 18:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple serum metabolites', 'timeFrame': '11.5 hours (after lunch at 19:00PM)', 'description': 'The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple urinary metabolites', 'timeFrame': 'Baseline (overnight urine sample collected at 7:30AM)', 'description': 'The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple urinary metabolites', 'timeFrame': '3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)', 'description': 'The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple urinary metabolites', 'timeFrame': '4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)', 'description': 'The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple urinary metabolites', 'timeFrame': '6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)', 'description': 'The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}, {'measure': 'Intensities of multiple urinary metabolites', 'timeFrame': '8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)', 'description': 'The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vegetable metabolite signature', 'human serum/urinary metabolite', 'liquid chromatography mass spectrometry'], 'conditions': ['Vegetable Signature Documentation With Metabolomic Technique']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform dietary intervention studies on a variety of vegetables.', 'detailedDescription': 'Plant-based foods have always been an important component of a healthy diet. High intake of plant foods may not only maintain normal bodily functions through the provision of dietary fiber, vitamins, and minerals but also relieve symptoms and prevent diseases. Many studies have pointed out that high intake of plant foods may reduce the incidence of non-communicable disease. Past research investigating the effect of phytochemicals has usually been limited to single substances or single foods. However, a number of researchers have pointed out that phytonutrients and dietary components are likely to act synergistically.Health effects and mechanisms of phytonutrients in combination have not been carefully studied in population settings. The technology of metabolomics has enabled the simultaneous measurement of hundreds of small molecules in biological samples. Exploring the change of metabolites after feeding can not only help us understand the role of plant foods, but may also provide opportunities to assess plant food intake levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18.5\\~30 kg/m2\n* non-smoker\n* non-alcoholic\n\nExclusion Criteria:\n\n* Unwilling to stop taking the dietary supplements that may affect the experiment result.\n* Unwilling to take the provided meal during the designated period.\n* Taking hypertension or diabetes drugs.\n* Diagnosed immune diseases (such as allergic diseases, autoimmune diseases, etc.), liver diseases, metabolic diseases (such as hyperthyroidism or hypothyroidism), or other not suitable for the dietary study.\n* Diagnosed cancer or other severe diseases.\n* Suffered from urinary tract infection or took antibiotic in the past three months'}, 'identificationModule': {'nctId': 'NCT03483558', 'briefTitle': 'Vegetable Signature From Human Metabolomics Responses', 'organization': {'class': 'OTHER', 'fullName': 'National Health Research Institutes, Taiwan'}, 'officialTitle': 'Dietary Intervention Studies on a Variety of Vegetables', 'orgStudyIdInfo': {'id': 'NHRI_EC0991003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Participants were fed a standardized diet (without any vegetables) in this experiment.', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Spinach', 'description': 'Participants were fed a standardized diet with 200g spinach in this experiment.', 'interventionNames': ['Other: Spinach']}, {'type': 'EXPERIMENTAL', 'label': 'Celery', 'description': 'Participants were fed a standardized diet with 200g celery in this experiment.', 'interventionNames': ['Other: Celery']}, {'type': 'EXPERIMENTAL', 'label': 'Onion', 'description': 'Participants were fed a standardized diet with 200g onion in this experiment.', 'interventionNames': ['Other: Onion']}, {'type': 'EXPERIMENTAL', 'label': 'Mixed Vegetables', 'description': 'Participants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment.', 'interventionNames': ['Other: Mixed Vegetables']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'A standardized diet without any vegetables was provided.', 'armGroupLabels': ['Control']}, {'name': 'Spinach', 'type': 'OTHER', 'description': 'A standardized diet with 200g spinach was provided.', 'armGroupLabels': ['Spinach']}, {'name': 'Celery', 'type': 'OTHER', 'description': 'A standardized diet with 200g celery was provided.', 'armGroupLabels': ['Celery']}, {'name': 'Onion', 'type': 'OTHER', 'description': 'A standardized diet with 200g onion was provided.', 'armGroupLabels': ['Onion']}, {'name': 'Mixed Vegetables', 'type': 'OTHER', 'description': 'A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.', 'armGroupLabels': ['Mixed Vegetables']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wen-Harn Pan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Health Research Institutes, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academia Sinica, Taiwan', 'class': 'OTHER'}, {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}