Kimchi and Gut Health

Official title

Kimchi and Gut Health - Kimchi Effects on the Human Gut Microbiome

Overview

The goal of this study is to learn about the effects of eating kimchi on the gut health of healthy adults in the USA. The investigators will be researching the changes in the gut microbiome, biomarkers of gut health and cardiometabolic health after consuming fermented and unfermented cabbage. The main questions it aims to answer are: Does eating kimchi (fermented cabbage) result in enrichment of lactic acid bacteria in the stools of participants? Does eating kimchi result in metabolic changes in the gut microbiome, biomarkers of gut and cardiometabolic health of participants? Researchers will compare a group of participants eating fermented cabbage (kimchi) daily to a group of participants eating non-fermented cabbage daily. Participants will: Eat kimchi or cabbage daily for 3 weeks. Visit the study site for brief visits up to 5 times. Have blood drawn and provide a fecal sample 2 times - at beginning and end of the 3 week study. Keep occasional records of food intake and questionnaires about any gastrointestinal symptoms that participants may have.

Interventions

• Other 60 grams per day of intervention food
  Non-fermented cabbage
• Other 60 grams per day of intervention food
  Kimchi fermented cabbage

Primary outcome measures

• Change from baseline in fecal Lactic Acid Bacteria (LAB) [Time frame: Baseline and week 3]

Secondary outcome measures (7)

• Fecal Metabolites - Change in short chain fatty acids (SCFA) and secondary bile acids (BA) [Time frame: Baseline and 3 weeks]
• Gut integrity and health - Change in fecal calprotectin, fecal lipocalin, and fecal sIGA [Time frame: Baseline and 3 weeks]
• Gut integrity and health - Change in plasma lipopolysaccharide binding protein (LBP), lipopolysaccharide (LPS), zonulin, and sCD14 [Time frame: Baseline and 3 weeks]
• Immune biomarkers - Change in plasma IL-6, TNF-alpha, hsCRP [Time frame: Baseline and 3 weeks]
• Cardiometabolic biomarkers - Change in lipid panel (TC, LDL, HDL, TG), and oxidized LDL (oxLDL) [Time frame: Baseline and 3 weeks]
• Qualitative self-assessment of gut associated health - Change in Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: Baseline and 3 weeks]
• Qualitative self-assessment of gut associated health - Change in Digestion-associated Quality of Life Questionnaire (DQLQ) [Time frame: Baseline and 3 weeks]

Eligibility criteria

Inclusion criteria

• BMI of 25-30 kg/m2
• No or occasional consumption of kimchi (3 or fewer times per week)
• Willing to eat study food every day for 3 weeks
• Willing to participate in study protocols

Exclusion criteria

• Allergy to cabbage and /or cruciferous family vegetables
• Allergy to kimchi ingredients such as shellfish and fish sauce
• Daily consumption of kimchi
• Diagnosed digestive issues such as irritable bowel syndrome (IBS) or gastrointestinal inflammatory bowel disease (IBD) or conditions such as Crohn's disease
• Previous bowel surgery that disrupts the digestive flow, motility or gastric emptying process
• Antibiotics used in the 2 months prior to enrollment
• Unwillingness to discontinue probiotics during study and washout period
• Active diagnosis and/or treatment for cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 2 centers

• Ragle Human Nutrition Center — Davis
• UC Davis Ragle Human Nutrition Research Center — Davis

Identifiers

NCT: NCT07435831 · 2325615-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗