Clinical trial NCT05917392: Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes
Official title: Effects of Polyphenol and Lactobacillus Rhamnosus Supplementation in Fermented Vegetables (Kimchi) on Gut Microbiota, DNA Methylation and Serum Proteomes in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: DNA methylation
proteomic
microbiota
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: ฺBMI
timeFrame: 2 months
measure: gut bacterial flora
timeFrame: 2 months
Secondary outcomes:
measure: DNA methylation of inflammation and anti-inflammation gene
timeFrame: 2 months
measure: Serum proteome
timeFrame: 2 months
Other outcomes:
measure: The differences between the treatment groups and the non-obese group for exploratory variables
timeFrame: baseline
Locations:
city: Bangkok
country: Thailand
facility: Jintana Sirivarasai
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Jintana Sirivarasai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: