Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-25 @ 7:51 AM
Study NCT ID:
NCT05917392
Status:
UNKNOWN
Last Update Posted:
2023-06-23
First Post:
2023-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D059808', 'term': 'Polyphenols'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-05-21', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The differences between the treatment groups and the non-obese group for exploratory variables', 'timeFrame': 'baseline', 'description': 'Changes in blood biochemistry (lipid profile, inflammatory cytokine level), protein expression (up and dow-regulation), %methylation (hypomethylation and hypermethylation) and concentration of specific bacterial groups'}], 'primaryOutcomes': [{'measure': 'ฺBMI', 'timeFrame': '2 months', 'description': 'changes in BMI for evaluating obesity at 2 months from baseline'}, {'measure': 'gut bacterial flora', 'timeFrame': '2 months', 'description': 'Changes and differences of the gut bacterial flora will be addressed in detail, e.g. changes in concentration of specific bacterial groups (e.g. Lactobacillus) before and after the intervention period.'}], 'secondaryOutcomes': [{'measure': 'DNA methylation of inflammation and anti-inflammation gene', 'timeFrame': '2 months', 'description': 'changes in methylation (hypomethylation and hypermethylation)'}, {'measure': 'Serum proteome', 'timeFrame': '2 months', 'description': 'changes in protein expression (up and dow-regulation)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DNA methylation', 'proteomic', 'microbiota'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Participants will ask to answer questionnaire related to general characteristic, lifestyle, dietary pattern and undergo physical examination and measurement of body composition. The subjects will be divided into 2 groups: healthy control and intervention. The intervention group was divided into 3 subgroups: the fermented vegetable (kimchi) group, the kimchi supplemented with polyphenol (Vitexin) group, or the kimchi supplemented with probiotic (Lactobacillus rhamnosus) group. The intervention group will be instructed to consume 1 pack of kimchi per day (50 g/pack) with lunch for 2 months.', 'detailedDescription': "The subjects will be divided into 2 groups: healthy control and intervention. The intervention group was divided into 3 subgroups: the fermented vegetable (kimchi) group, the kimchi supplemented with polyphenol (Vitexin) group, or the kimchi supplemented with probiotic (Lactobacillus rhamnosus) group. The intervention group will be instructed to consume 1 pack of kimchi per day (50 g/pack) with lunch for 2 months. During the study, participants will be strongly encouraged to avoid consuming prebiotics or probiotic supplements, as well as foods such as yogurt, sour milk, fermented vegetables, and fermented fruits, especially 2 weeks before the blood and fecal examination. Compliance will be assessed by monitoring product side effects through follow-up phone calls every week to check on participants' symptoms and assessing the number of sachets or packs they actually consume."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: for the intervention group\n\n* age 35-50 years, BMI of ≥23 kg/m2, presence or absence of metabolic syndrome (not treated by medication) according to the National Cholesterol Education Program (NCEP ATPIII 2007), in collaboration with the International Diabetes Federation (IDF) and the World Health Organization (WHO), metabolic syndrome\n\nExclusion Criteria:for the intervention group\n\n* participants declined or withdrew, history of taking antibiotics in the 12 weeks prior to the project, history of using prebiotics or probiotic supplements on a regular basis, history of eating foods in these groups regularly, including yogurt, sour milk, fermented vegetables, and fermented fruits, history of taking drugs or weight loss products in the previous 6 months, history of diarrhea or constipation regularly, history of cure for ulcerative colitis, history of underlying disease that requires continuous medication, history of taking laxatives regularly, history of severe gastrointestinal disease, and history of illnesses such as thyroid disease, cancer, autoimmune diseases, kidney disease and hypertension etc.'}, 'identificationModule': {'nctId': 'NCT05917392', 'briefTitle': 'Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effects of Polyphenol and Lactobacillus Rhamnosus Supplementation in Fermented Vegetables (Kimchi) on Gut Microbiota, DNA Methylation and Serum Proteomes in Overweight and Obese Women', 'orgStudyIdInfo': {'id': 'COA. MURA2023/127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supplementation-standard', 'description': 'Supplementation with Kimchi 50 gram daily for two months', 'interventionNames': ['Dietary Supplement: Fermented Vegetables (Kimchi) supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Supplementation with probiotic', 'description': 'Supplementation with Kimchi plus LGG 50 gram daily for two months', 'interventionNames': ['Dietary Supplement: probiotic']}, {'type': 'EXPERIMENTAL', 'label': 'Supplementation with polyphenol', 'description': 'Supplementation with Kimchi plus polyphenol 50 gram daily for two months', 'interventionNames': ['Dietary Supplement: polyphenol']}], 'interventions': [{'name': 'Fermented Vegetables (Kimchi) supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Kimchi supplementation'], 'description': 'Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota', 'armGroupLabels': ['Supplementation-standard']}, {'name': 'probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation with Kimchi plus LGG 50 grams daily for two months', 'armGroupLabels': ['Supplementation with probiotic']}, {'name': 'polyphenol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation with Kimchi plus polyphenol 50 grams daily for two months', 'armGroupLabels': ['Supplementation with polyphenol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Jintana Sirivarasai, Ph.D', 'role': 'CONTACT', 'email': 'jintana.sir@mahidol.ac.th', 'phone': '662-201-1483'}, {'name': 'Prapimporn Chattranukulchai, MD.', 'role': 'CONTACT', 'email': 'sprapimporn@gmail.com', 'phone': '662-201-1992'}], 'facility': 'Jintana Sirivarasai', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Jintana Sirivarasai, Ph.D', 'role': 'CONTACT', 'email': 'jintana.sir@mahidol.ac.th', 'phone': '662-201-1483'}, {'name': 'Prapimporn Chattranukulchai, MD', 'role': 'CONTACT', 'email': 'sprapimporn@gmail.com', 'phone': '662-201-1922'}], 'overallOfficials': [{'name': 'Jintana Sirivarasai, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 12 months after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'After summary data are published and others can access via journal website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}