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

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Dietary Supplement: probiotic; Dietary Supplement: polyphenol; Dietary Supplement: Fermented Vegetables (Kimchi) supplementation

• Registration Number: NCT05917392
• Lead Sponsor: Mahidol University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-21
• Status Verified: 2023-06
• Study Start: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23
• Primary Completion: 2023-11-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementation with probiotic	probiotic	Supplementation with Kimchi plus LGG 50 gram daily for two months
Supplementation with polyphenol	polyphenol	Supplementation with Kimchi plus polyphenol 50 gram daily for two months
Supplementation-standard	Fermented Vegetables (Kimchi) supplementation	Supplementation with Kimchi 50 gram daily for two months

Primary Outcome Measures

Name	Time	Method
gut bacterial flora	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.
ฺBMI	2 months	changes in BMI for evaluating obesity at 2 months from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jintana Sirivarasai; 🇹🇭 Bangkok, Thailand