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Effect of Kimchi Intake on Body Fat in Overweight Subjects

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kimchi
Placebo
Sponsored by
World Institute of Kimchi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Kimchi, Lactic acid bacteria

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Kimchi inoculated Leuconostoc mesenteroides

    Kimchi

    Lactose

    Arm Description

    3,600mg/day containing 80% Kimchi inoculated Leuconostoc mesenteroides powder (3 tablets 3 times per day after meals over the 16-week regimen)

    3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen)

    3,600mg/day containing lactose placebo capsules to look identical. (3 tablets 3 times per day after meals over the 16-week regimen)

    Outcomes

    Primary Outcome Measures

    Fat mass change in 16-week
    Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)

    Secondary Outcome Measures

    Changes in body mass index (BMI)
    Changes in body weight
    Changes in waist to hip ratio (WHR)
    Changes in Body fat ratio (%)
    Body fat ratio (%) will be assessed by DEXA
    Changes in Body lean mass (kg)
    Body lean mass (kg) will be assessed by DEXA
    Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein)
    Changes in free fatty acids (FFA) concentration
    Changes in HbA1c
    Changes in fasting glucose concentration
    Changes in insulin resistance
    Changes in HOMA-IR value
    HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
    Changes of serum hs-CRP
    Changes in adiponection
    Changes in leptin
    Change of Microbiota composite

    Full Information

    First Posted
    June 2, 2023
    Last Updated
    June 9, 2023
    Sponsor
    World Institute of Kimchi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05898802
    Brief Title
    Effect of Kimchi Intake on Body Fat in Overweight Subjects
    Official Title
    Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    World Institute of Kimchi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Kimchi, Lactic acid bacteria

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Participants or study staff working with them will not know what supplements they are receiving.
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kimchi inoculated Leuconostoc mesenteroides
    Arm Type
    Experimental
    Arm Description
    3,600mg/day containing 80% Kimchi inoculated Leuconostoc mesenteroides powder (3 tablets 3 times per day after meals over the 16-week regimen)
    Arm Title
    Kimchi
    Arm Type
    Experimental
    Arm Description
    3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen)
    Arm Title
    Lactose
    Arm Type
    Placebo Comparator
    Arm Description
    3,600mg/day containing lactose placebo capsules to look identical. (3 tablets 3 times per day after meals over the 16-week regimen)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Kimchi
    Intervention 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Lactose with kimchi flavor
    Primary Outcome Measure Information:
    Title
    Fat mass change in 16-week
    Description
    Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)
    Time Frame
    8 weeks, 16 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in body mass index (BMI)
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in body weight
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in waist to hip ratio (WHR)
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in Body fat ratio (%)
    Description
    Body fat ratio (%) will be assessed by DEXA
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in Body lean mass (kg)
    Description
    Body lean mass (kg) will be assessed by DEXA
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein)
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in free fatty acids (FFA) concentration
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in HbA1c
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in fasting glucose concentration
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in insulin resistance
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in HOMA-IR value
    Description
    HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes of serum hs-CRP
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in adiponection
    Time Frame
    8 weeks, 16 weeks
    Title
    Changes in leptin
    Time Frame
    8 weeks, 16 weeks
    Title
    Change of Microbiota composite
    Time Frame
    8 weeks, 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sung wook Hong, ph.D
    Phone
    +82626101760
    Email
    swhong@wikim.re.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wooje Lee, ph.D
    Phone
    +82626101811
    Email
    wjlee@wikim.re.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Kimchi Intake on Body Fat in Overweight Subjects

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