- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435831
Kimchi and Gut Health
Kimchi and Gut Health - Kimchi Effects on the Human Gut Microbiome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Recruiting
- Ragle Human Nutrition Center
-
Contact:
- Francene Steinberg, PhD
- Phone Number: 530-752-0120
- Email: fmsteinberg@ucdavis.edu
-
Davis, California, United States, 95616
- Recruiting
- UC Davis Ragle Human Nutrition Research Center
-
Contact:
- Francene Steinberg, PhD
- Phone Number: 530-752-0160
- Email: fmsteinberg@ucdavis.edu
-
Contact:
- Jody Randolph
- Phone Number: 5307527620
- Email: jmrandolph@ucdavis.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kimchi
|
Non-fermented cabbage
Kimchi fermented cabbage
|
|
Active Comparator: Cabbage
|
Non-fermented cabbage
Kimchi fermented cabbage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in fecal Lactic Acid Bacteria (LAB)
Time Frame: Baseline and week 3
|
Baseline and week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fecal Metabolites - Change in short chain fatty acids (SCFA) and secondary bile acids (BA)
Time Frame: Baseline and 3 weeks
|
Baseline and 3 weeks
|
|
|
Gut integrity and health - Change in fecal calprotectin, fecal lipocalin, and fecal sIGA
Time Frame: Baseline and 3 weeks
|
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
|
Baseline and 3 weeks
|
|
|
Immune biomarkers - Change in plasma IL-6, TNF-alpha, hsCRP
Time Frame: Baseline and 3 weeks
|
Baseline and 3 weeks
|
|
|
Cardiometabolic biomarkers - Change in lipid panel (TC, LDL, HDL, TG), and oxidized LDL (oxLDL)
Time Frame: Baseline and 3 weeks
|
Baseline and 3 weeks
|
|
|
Qualitative self-assessment of gut associated health - Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline and 3 weeks
|
This questionnaire rates gastrointestinal symptoms over the past 7 days.
A higher score indicates presence and increasing severity of symptoms and level of discomfort.
|
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
|
This questionnaire measures the effect of digestive symptoms on daily life over the past 7 days.
A higher score indicates a lower (worse) digestion-associated Quality of Life.
|
Baseline and 3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and 3 weeks
|
To derive the Body Mass Index (BMI) the following will be done: Height will be measured in meters.
Weight will be measured in kilograms.
These values will be aggregated to arrive at one reported value to report BMI in kg/m2
|
Baseline and 3 weeks
|
|
Dietary Records and nutritional analysis of Macronutrients
Time Frame: Baseline, week 1 of intervention, week 3 of intervention
|
ASA24 (Automated Self Assessment of diet on the NIH website) will be used to record 24 hours of diet intake.
Macronutrients will be measured in grams/day.
|
Baseline, week 1 of intervention, week 3 of intervention
|
|
Dietary records and assessment of Fiber intake
Time Frame: Baseline, weeks 1 and 3
|
ASA24 (Automated Self Assessment of diet on the NIH website) will be used to record 24 hours of diet intake.
Dietary fiber will be measured in grams/day.
|
Baseline, weeks 1 and 3
|
|
Waist Circumference
Time Frame: Baseline and 3 weeks
|
Waist circumference will be measured in centimeters
|
Baseline and 3 weeks
|
|
Blood Pressure
Time Frame: Baseline and 3 weeks
|
Blood pressure will be measured by automated upper arm cuff to read systolic and diastolic pressure in units of mm Hg.
Normal pressure is considered 120/80 mm Hg.
|
Baseline and 3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2325615-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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