Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes

June 15, 2023 updated by: Mahidol University

Effects of Polyphenol and Lactobacillus Rhamnosus Supplementation in Fermented Vegetables (Kimchi) on Gut Microbiota, DNA Methylation and Serum Proteomes in Overweight and Obese Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: for the intervention group

  • 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

Exclusion Criteria:for the intervention group

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Supplementation-standard
Supplementation with Kimchi 50 gram daily for two months
Dietary supplement: Fermented Vegetables (Kimchi) supplementation
Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota
Other Names:
  • Kimchi supplementation
Experimental: Supplementation with probiotic
Supplementation with Kimchi plus LGG 50 gram daily for two months
Dietary supplement: probiotic
Supplementation with Kimchi plus LGG 50 grams daily for two months
Experimental: Supplementation with polyphenol
Supplementation with Kimchi plus polyphenol 50 gram daily for two months
Dietary supplement: polyphenol
Supplementation with Kimchi plus polyphenol 50 grams daily for two months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ฺBMI
Time Frame: 2 months
changes in BMI for evaluating obesity at 2 months from baseline
2 months
gut bacterial flora
Time Frame: 2 months
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.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DNA methylation of inflammation and anti-inflammation gene
Time Frame: 2 months
changes in methylation (hypomethylation and hypermethylation)
2 months
Serum proteome
Time Frame: 2 months
changes in protein expression (up and dow-regulation)
2 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The differences between the treatment groups and the non-obese group for exploratory variables
Time Frame: baseline
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jintana Sirivarasai, Ph.D, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COA. MURA2023/127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 12 months after publication

IPD Sharing Access Criteria

After summary data are published and others can access via journal website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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