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

NCT ID: NCT05917392

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supplementation-standard

Supplementation with Kimchi 50 gram daily for two months

Group Type ACTIVE_COMPARATOR

Fermented Vegetables (Kimchi) supplementation

Intervention Type DIETARY_SUPPLEMENT

Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota

Supplementation with probiotic

Supplementation with Kimchi plus LGG 50 gram daily for two months

Group Type EXPERIMENTAL

probiotic

Intervention Type DIETARY_SUPPLEMENT

Supplementation with Kimchi plus LGG 50 grams daily for two months

Supplementation with polyphenol

Supplementation with Kimchi plus polyphenol 50 gram daily for two months

Group Type EXPERIMENTAL

polyphenol

Intervention Type DIETARY_SUPPLEMENT

Supplementation with Kimchi plus polyphenol 50 grams daily for two months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fermented Vegetables (Kimchi) supplementation

Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota

Intervention Type DIETARY_SUPPLEMENT

probiotic

Supplementation with Kimchi plus LGG 50 grams daily for two months

Intervention Type DIETARY_SUPPLEMENT

polyphenol

Supplementation with Kimchi plus polyphenol 50 grams daily for two months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kimchi supplementation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jintana Sirivarasai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jintana Sirivarasai

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jintana Sirivarasai, Ph.D

Role: CONTACT

662-201-1483

Prapimporn Chattranukulchai, MD

Role: CONTACT

662-201-1922

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jintana Sirivarasai, Ph.D

Role: primary

662-201-1483

Prapimporn Chattranukulchai, MD.

Role: backup

662-201-1992

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COA. MURA2023/127

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maternal & Offspring Microbiome Study
NCT05123612 ACTIVE_NOT_RECRUITING NA