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

Mahidol University

Status: Not yet enrolling

Conditions: Obesity

Treatments: Dietary Supplement: Fermented Vegetables (Kimchi) supplementation; Dietary Supplement: polyphenol; Dietary Supplement: probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05917392

COA. MURA2023/127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Supplementation-standard

Active Comparator group

Description:

Supplementation with Kimchi 50 gram daily for two months

Treatment:

Dietary Supplement: Fermented Vegetables (Kimchi) supplementation

Supplementation with probiotic

Experimental group

Description:

Supplementation with Kimchi plus LGG 50 gram daily for two months

Treatment:

Dietary Supplement: probiotic

Supplementation with polyphenol

Experimental group

Description:

Supplementation with Kimchi plus polyphenol 50 gram daily for two months

Treatment:

Dietary Supplement: polyphenol