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

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: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Fermented Vegetables (Kimchi) supplementation; Dietary supplement: probiotic; Dietary supplement: polyphenol

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: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jintana Sirivarasai, Ph.D; Phone Number: 662-201-1483; Email: jintana.sir@mahidol.ac.th
• Study Contact Backup: Name: Prapimporn Chattranukulchai, MD; Phone Number: 662-201-1922; Email: sprapimporn@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Jintana Sirivarasai
    • Contact: Jintana Sirivarasai, Ph.D; Phone Number: 662-201-1483; Email: jintana.sir@mahidol.ac.th
    • Contact: Prapimporn Chattranukulchai, MD.; Phone Number: 662-201-1992; Email: sprapimporn@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
ฺBMI	changes in BMI for evaluating obesity at 2 months from baseline	2 months
gut bacterial flora	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

Outcome Measure	Measure Description	Time Frame
DNA methylation of inflammation and anti-inflammation gene	changes in methylation (hypomethylation and hypermethylation)	2 months
Serum proteome	changes in protein expression (up and dow-regulation)	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences between the treatment groups and the non-obese group for exploratory variables	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

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Jintana Sirivarasai, Ph.D, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: proteomic; microbiota; DNA methylation
• Other Study ID 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