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

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05917392
Collaborator
(none)
90
1
3
13.5
6.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fermented Vegetables (Kimchi) supplementation
  • Dietary Supplement: probiotic
  • Dietary Supplement: polyphenol
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Supplementation-standard

Supplementation with Kimchi 50 gram daily for two months

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
Other Names:
  • Kimchi supplementation
  • Experimental: Supplementation with probiotic

    Supplementation with Kimchi plus LGG 50 gram daily for two months

    Dietary Supplement: probiotic
    Supplementation with Kimchi plus LGG 50 grams daily for two months

    Experimental: Supplementation with polyphenol

    Supplementation with Kimchi plus polyphenol 50 gram daily for two months

    Dietary Supplement: polyphenol
    Supplementation with Kimchi plus polyphenol 50 grams daily for two months

    Outcome Measures

    Primary Outcome Measures

    1. ฺBMI [2 months]

      changes in BMI for evaluating obesity at 2 months from baseline

    2. gut bacterial flora [2 months]

      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.

    Secondary Outcome Measures

    1. DNA methylation of inflammation and anti-inflammation gene [2 months]

      changes in methylation (hypomethylation and hypermethylation)

    2. Serum proteome [2 months]

      changes in protein expression (up and dow-regulation)

    Other Outcome Measures

    1. The differences between the treatment groups and the non-obese group for exploratory variables [baseline]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jintana Sirivarasai Bangkok Thailand 10400

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Jintana Sirivarasai, Ph.D, Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05917392
    Other Study ID Numbers:
    • COA. MURA2023/127
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahidol University

    Study Results

    No Results Posted as of Jun 23, 2023