Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-13 @ 11:24 AM
Study NCT ID:
NCT05898802
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Kimchi Intake on Body Fat in Overweight Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants or study staff working with them will not know what supplements they are receiving.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-05', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat mass change in 12-week', 'timeFrame': 'Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)', 'description': 'Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)'}], 'secondaryOutcomes': [{'measure': 'Changes in body mass index (BMI)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'BMI will be calculated as weight (kg) divided by height squared (m²) at baseline, week 6, and week 12.'}, {'measure': 'Changes in body weight', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Body weight will be measured using a calibrated digital scale at baseline, week 6, and week 12.'}, {'measure': 'Changes in waist to hip ratio (WHR)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Waist to hip ratio will be calculated by dividing waist circumference by hip circumference at baseline, week 6, and week 12.'}, {'measure': 'Changes in Body fat ratio (%)', 'timeFrame': 'Baseline and Week 12', 'description': 'Body fat ratio (%) will be assessed by DEXA'}, {'measure': 'Changes in Body lean mass (kg)', 'timeFrame': 'Baseline and Week 12', 'description': 'Body lean mass (kg) will be assessed by DEXA'}, {'measure': 'Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein)', 'timeFrame': 'Baseline and Week 12', 'description': 'Fasting blood samples will be collected to measure total cholesterol, triglycerides, LDL-C, and HDL-C at baseline and week 12'}, {'measure': 'Changes in free fatty acids (FFA) concentration', 'timeFrame': 'Baseline and Week 12', 'description': 'Serum free fatty acid concentration will be measured at baseline and week 12.'}, {'measure': 'Changes in HbA1c', 'timeFrame': 'Baseline and Week 12', 'description': 'HbA1c levels will be measured at baseline and week 12 to assess glycemic control.'}, {'measure': 'Changes in fasting glucose concentration', 'timeFrame': 'Baseline and Week 12', 'description': 'Fasting blood glucose concentration will be measured at baseline and week 12.'}, {'measure': 'Changes in insulin resistance', 'timeFrame': 'Baseline and Week 12', 'description': 'Insulin resistance will be assessed using fasting insulin and glucose values at baseline and week 12.'}, {'measure': 'Changes in HOMA-IR value', 'timeFrame': 'Baseline and Week 12', 'description': 'HOMA-IR will be calculated as \\[fasting insulin (μIU/mL) x fasting glucose (mg/dL)\\] / 405 at baseline and week 12.'}, {'measure': 'Changes of serum hs-CRP', 'timeFrame': 'Baseline and Week 12', 'description': 'High sensitivity C-reactive protein will be measured at baseline and week 12.'}, {'measure': 'Changes in adiponection', 'timeFrame': 'Baseline and Week 12', 'description': 'Serum adiponectin levels will be measured at baseline and week 12.'}, {'measure': 'Changes in leptin', 'timeFrame': 'Baseline and Week 12', 'description': 'Serum leptin levels will be measured at baseline and week 12.'}, {'measure': 'Change of Microbiota composite', 'timeFrame': 'Baseline and Week 12', 'description': 'Fecal microbiota composition will be assessed at baseline and week 12 using 16S rRNA sequencing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kimchi', 'Lactic acid bacteria'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '41249184', 'type': 'DERIVED', 'citation': 'Lee W, Moon HR, Choi H, Lee HJ, Kim Y, Kim HJ, Yun YR, Kwon MS, Hong SW. Single-cell RNA sequencing reveals that kimchi dietary intervention modulates human antigen-presenting and CD4(+) T cells. NPJ Sci Food. 2025 Nov 17;9(1):236. doi: 10.1038/s41538-025-00593-7.'}]}, 'descriptionModule': {'briefSummary': 'Kimchi, a traditional Korean food, is prepared through the fermentation of various ingredients. It has been reported that kimchi contains beneficial nutrients from its raw materials, as well as lactic acid bacteria (LAB) and their byproducts produced during fermentation. LAB play an important role in the fermentation process, during which the dominant LAB species emerge and undergo a transition process. Depending on the species and strain of LAB, it has specific functions such as promoting weight loss, reducing inflammation, and lowering cholesterol levels. In this study, the effects of kimchi produced from traditional recipe or kimchi fermented with lactic acid bacteria, which have anti-obesity effects, on body composition changes and metabolic disease index will be investigated in subjects with a BMI of between 23\\~30kg / m2.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled clinical trial to investigate the anti-obesity effect of kimchi fermented with the addition of specific lactic acid bacteria.\n\nTwo different kimchi, one traditional kimchi and one fermented with a lactic acid bacteria having anti-obesity effect, hereafter starter kimchi, are flash freeze dried, powdered and encapsulated. Specifically, subjects with a BMI of between 23\\~30kg/m2 take 1,200 mg of traditional kimchi or starter kimchi capsules three times per day before each meal, for a total of 3,600 mg per day. As a control, subjects with a BMI of 23 to 30 kg/m2 take lactose capsules in a similar form and in the same amount. The total study period is 16 weeks of intake of kimchi capsules or placebo capsules, excluding the 2 weeks of preparation period for subject selection. Before and after taking the kimchi capsule or the placebo capsule, the following evaluation criteria of the subject will be measured; DEXA (Dual Energy X-ray Absorptiometry), BMI, Weight, Waist to Hip ratio (WHR), total cholesterol, triglyceride, HDL-C, calculate LDL-C, FFA, HbA1c, glucose, insulin, HOMA-IR, hs-CRP, Adiponectin, Leptin. Also, Changes in gut microbiome composition will be determined by measuring bacterial population levels in stool samples collected before and after taking kimchi capsules or placebo capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to consent to study participation and to comply with study requirements\n* Male and female subjects, 20-65 years of age\n* BMI of 23-30 kg/m2\n* Those who agreed not to consume Kimchi during the clinical study\n\nExclusion Criteria:\n\n* Patients with crucial cerebrovascular disease (cerebral infarction, cerebral hemorrhage etc.), or heart failure (angina pectoris, myocardial infarction, heart failure, arrhythmia etc.) or malignancy within 6 months\n* Uncontrolled hypertension (Elevated blood pressure (\\>160/\\>100))\n* Thyroid function test abnormality\n* Patients with significantly impaired kidney function: serume creatinine levels ≥2 times upper limit of normal\n* Patients with significantly impaired liver function: ALT or AST≥3 times upper limit of normal\n* Irregular or occasional gastrointestinal disorders (heartburn, indigestion, etc.)\n* Having taken drugs with a known influence on weight in the previous 1 month, such as diet pills, anti-depression drugs, beta-blockers, diuretic, contraceptives, corticosteroids, or female hormones\n* Participation in other dietary programmes or services within 3 months\n* Participation in other clinical trials within the past 1 month\n* Alcohol abuse\n* Quitted smoking within 3 months\n* Pregnancy or lactation or planning on becoming pregnant\n* Have a Kimchi allergy\n* Those who are judged unsuitable by the researcher for other reasons\n* Taking probiotics within 2 weeks'}, 'identificationModule': {'nctId': 'NCT05898802', 'briefTitle': 'Effect of Kimchi Intake on Body Fat in Overweight Subjects', 'organization': {'class': 'OTHER_GOV', 'fullName': 'World Institute of Kimchi'}, 'officialTitle': 'Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'WiKim_2210-037-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kimchi inoculated Leuconostoc mesenteroides', 'description': '3,600mg/day containing 80% Kimchi inoculated Leuconostoc mesenteroides powder (3 tablets 3 times per day after meals over the 16-week regimen)', 'interventionNames': ['Dietary Supplement: Kimchi']}, {'type': 'EXPERIMENTAL', 'label': 'Kimchi', 'description': '3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen)', 'interventionNames': ['Dietary Supplement: Kimchi']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lactose', 'description': '3,600mg/day containing lactose placebo capsules to look identical. (3 tablets 3 times per day after meals over the 16-week regimen)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Kimchi', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two different kimchi, one traditional kimchi and one fermented with a lactic acid bacteria having anti-obesity effect, hereafter starter kimchi, are flash freeze dried, powdered and encapsulated.', 'armGroupLabels': ['Kimchi', 'Kimchi inoculated Leuconostoc mesenteroides']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactose with kimchi flavor', 'armGroupLabels': ['Lactose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Wooje Lee, ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'World Institute of Kimchi'}, {'name': 'Myungjun Shin, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pusan National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'World Institute of Kimchi', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Woo Je Lee', 'investigatorAffiliation': 'World Institute of Kimchi'}}}}