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

NCT05917392 | Unknown DMC

• 1 other identifier: COA. MURA2023/127
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

DNA methylation; proteomic; microbiota

Outcome Measures

Primary Outcomes (2)

• ฺ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 Outcomes (2)

• DNA methylation of inflammation and anti-inflammation gene

  2 months

• Serum proteome

  2 months

Other Outcomes (1)

• The differences between the treatment groups and the non-obese group for exploratory variables

  baseline

Study Arms (3)

Supplementation-standard

ACTIVE COMPARATOR

Supplementation with Kimchi 50 gram daily for two months

Dietary Supplement: Fermented Vegetables (Kimchi) supplementation

Supplementation with probiotic

EXPERIMENTAL

Supplementation with Kimchi plus LGG 50 gram daily for two months

Dietary Supplement: probiotic

Supplementation with polyphenol

EXPERIMENTAL

Supplementation with Kimchi plus polyphenol 50 gram daily for two months

Dietary Supplement: polyphenol

Interventions

Fermented Vegetables (Kimchi) supplementation DIETARY_SUPPLEMENT

Fermented Vegetables (Kimchi) supplementation with 50 gm daily for two months and effects of DNA methylation, serum proteome and microbiota

Also known as: Kimchi supplementation

Supplementation-standard

probiotic DIETARY_SUPPLEMENT

Supplementation with Kimchi plus LGG 50 grams daily for two months

Supplementation with probiotic

polyphenol DIETARY_SUPPLEMENT

Supplementation with Kimchi plus polyphenol 50 grams daily for two months

Supplementation with polyphenol

Eligibility Criteria

• Age: 35 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Jintana Sirivarasai

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Obesity

Interventions

Dietary Supplements; Probiotics; Polyphenols

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jintana Sirivarasai, Ph.D

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jintana Sirivarasai, Ph.D

CONTACT

662-201-1483; jintana.sir@mahidol.ac.th

Prapimporn Chattranukulchai, MD

CONTACT

662-201-1922; sprapimporn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 23, 2023
• Study Start: June 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: July 31, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 12 months after publication
• Access Criteria: After summary data are published and others can access via journal website

Locations

TH (1)