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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Fermented Vegetables (Kimchi) supplementation
* Dietary Supplement: probiotic
* Dietary Supplement: polyphenol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplementation-standard<br>Supplementation with Kimchi 50 gram daily for two months | Dietary Supplement: Fermented Vegetables (Kimchi) supplementation<br>* Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota<br>* Other names: Kimchi supplementation;|
| Experimental: Supplementation with probiotic<br>Supplementation with Kimchi plus LGG 50 gram daily for two months | Dietary Supplement: probiotic<br>* Supplementation with Kimchi plus LGG 50 grams daily for two months<br>|
| Experimental: Supplementation with polyphenol<br>Supplementation with Kimchi plus polyphenol 50 gram daily for two months | Dietary Supplement: polyphenol<br>* Supplementation with Kimchi plus polyphenol 50 grams daily for two months<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA methylation, proteomic, microbiota