- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05898802
Effect of Kimchi Intake on Body Fat in Overweight Subjects
Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Busan, Korea, Republic of, 49241
- Pusan National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willing to consent to study participation and to comply with study requirements
- Male and female subjects, 20-65 years of age
- BMI of 23-30 kg/m2
- Those who agreed not to consume Kimchi during the clinical study
Exclusion Criteria:
- 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
- Uncontrolled hypertension (Elevated blood pressure (>160/>100))
- Thyroid function test abnormality
- Patients with significantly impaired kidney function: serume creatinine levels ≥2 times upper limit of normal
- Patients with significantly impaired liver function: ALT or AST≥3 times upper limit of normal
- Irregular or occasional gastrointestinal disorders (heartburn, indigestion, etc.)
- 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
- Participation in other dietary programmes or services within 3 months
- Participation in other clinical trials within the past 1 month
- Alcohol abuse
- Quitted smoking within 3 months
- Pregnancy or lactation or planning on becoming pregnant
- Have a Kimchi allergy
- Those who are judged unsuitable by the researcher for other reasons
- Taking probiotics within 2 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kimchi inoculated Leuconostoc mesenteroides
3,600mg/day containing 80% Kimchi inoculated Leuconostoc mesenteroides powder (3 tablets 3 times per day after meals over the 16-week regimen)
|
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.
|
|
Experimental: Kimchi
3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen)
|
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.
|
|
Placebo Comparator: Lactose
3,600mg/day containing lactose placebo capsules to look identical.
(3 tablets 3 times per day after meals over the 16-week regimen)
|
Lactose with kimchi flavor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass change in 12-week
Time Frame: Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)
|
Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)
|
Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in body mass index (BMI)
Time Frame: Baseline, Week 6, Week 12
|
BMI will be calculated as weight (kg) divided by height squared (m²) at baseline, week 6, and week 12.
|
Baseline, Week 6, Week 12
|
|
Changes in body weight
Time Frame: Baseline, Week 6, Week 12
|
Body weight will be measured using a calibrated digital scale at baseline, week 6, and week 12.
|
Baseline, Week 6, Week 12
|
|
Changes in waist to hip ratio (WHR)
Time Frame: Baseline, Week 6, Week 12
|
Waist to hip ratio will be calculated by dividing waist circumference by hip circumference at baseline, week 6, and week 12.
|
Baseline, Week 6, Week 12
|
|
Changes in Body fat ratio (%)
Time Frame: Baseline and Week 12
|
Body fat ratio (%) will be assessed by DEXA
|
Baseline and Week 12
|
|
Changes in Body lean mass (kg)
Time Frame: Baseline and Week 12
|
Body lean mass (kg) will be assessed by DEXA
|
Baseline and Week 12
|
|
Changes in serum lipid profile (Total cholesterol, Triglycerides,Low-density lipoprotein,High density lipoprotein)
Time Frame: Baseline and Week 12
|
Fasting blood samples will be collected to measure total cholesterol, triglycerides, LDL-C, and HDL-C at baseline and week 12
|
Baseline and Week 12
|
|
Changes in free fatty acids (FFA) concentration
Time Frame: Baseline and Week 12
|
Serum free fatty acid concentration will be measured at baseline and week 12.
|
Baseline and Week 12
|
|
Changes in HbA1c
Time Frame: Baseline and Week 12
|
HbA1c levels will be measured at baseline and week 12 to assess glycemic control.
|
Baseline and Week 12
|
|
Changes in fasting glucose concentration
Time Frame: Baseline and Week 12
|
Fasting blood glucose concentration will be measured at baseline and week 12.
|
Baseline and Week 12
|
|
Changes in insulin resistance
Time Frame: Baseline and Week 12
|
Insulin resistance will be assessed using fasting insulin and glucose values at baseline and week 12.
|
Baseline and Week 12
|
|
Changes in HOMA-IR value
Time Frame: Baseline and Week 12
|
HOMA-IR will be calculated as [fasting insulin (μIU/mL) x fasting glucose (mg/dL)] / 405 at baseline and week 12.
|
Baseline and Week 12
|
|
Changes of serum hs-CRP
Time Frame: Baseline and Week 12
|
High sensitivity C-reactive protein will be measured at baseline and week 12.
|
Baseline and Week 12
|
|
Changes in adiponection
Time Frame: Baseline and Week 12
|
Serum adiponectin levels will be measured at baseline and week 12.
|
Baseline and Week 12
|
|
Changes in leptin
Time Frame: Baseline and Week 12
|
Serum leptin levels will be measured at baseline and week 12.
|
Baseline and Week 12
|
|
Change of Microbiota composite
Time Frame: Baseline and Week 12
|
Fecal microbiota composition will be assessed at baseline and week 12 using 16S rRNA sequencing.
|
Baseline and Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wooje Lee, ph.D, World Institute of Kimchi
- Study Chair: Myungjun Shin, M.D., Ph.D., Pusan National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WiKim_2210-037-119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
Clinical Trials on Kimchi
-
Mahidol UniversityNot yet recruiting