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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917392
• Other study ID #: COA. MURA2023/127
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: Mahidol University
• Contact: Jintana Sirivarasai, Ph.D
• Phone: 662-201-1483
• Email: jintana.sir[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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
• probiotic
Supplementation with Kimchi plus LGG 50 grams daily for two months
• polyphenol
Supplementation with Kimchi plus polyphenol 50 grams daily for two months

Locations

Country	Name	City	State
Thailand	Jintana Sirivarasai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	?BMI	changes in BMI for evaluating obesity at 2 months from baseline	2 months
Primary	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	DNA methylation of inflammation and anti-inflammation gene	changes in methylation (hypomethylation and hypermethylation)	2 months
Secondary	Serum proteome	changes in protein expression (up and dow-regulation)	2 months