Kimchi and Gut Health

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT07435831 · 2325615-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗