The Effect of Kimchi Powder Supplementation on Gut Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (KIMCHI-GUT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in IBS Severity Scoring System (IBS-SSS) total score
研究概览
简要总结
The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Kimchi powder supplementation on gut health in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) for 8 weeks.
详细描述
BACKGROUND AND RATIONALE
Kimchi, a traditional Korean fermented vegetable food, has been reported to possess a range of health-related functionalities including antioxidant, anti-aging, anti-obesity, and anti-cancer activities, and more recently, effects on cognitive function. These functionalities are attributed to the bioactive compounds, lactic acid bacteria, and fermentation metabolites present in kimchi.
Most recent research on the functionality of kimchi has focused on lactic acid bacteria isolated from kimchi rather than on kimchi itself. Although research on isolated strains is valuable, kimchi is a compositionally complex food manufactured from multiple ingredients, and its functionality as a whole food requires verification in cell and animal models followed by human studies. Among the health outcomes of interest, improvement of gut health warrants scientific verification, together with subsequent analysis of its relationship to related functions such as immune function.
The gut microbiome refers to the totality of microorganisms present in a given environment together with their genetic information. Microbial composition differs by body site and confers site-specific characteristics. The intestine harbors the largest and most diverse microbial population in the human body, and this population has been reported to exert substantial influence on health and on a wide range of diseases. As the association between the microbiome and health has become better established, research aimed at maintaining health and preventing disease through modulation of the microbiome has expanded. Substances secreted by intestinal microorganisms act on host cells and mediate diverse functions, making the study of host-microbe interactions and the regulation of cellular function an important area of investigation.
Evidence regarding changes in the human microbiome following kimchi consumption remains limited. Accordingly, this study performs human microbiome analysis in parallel with clinical assessment in order to examine the relationship between kimchi intake and improvement of gut health, to identify key intestinal microorganisms involved, and thereby to verify the health functionality of kimchi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, male or female, aged 20 to 70 years
- •Body mass index of 25 kg/m2 or more and less than 30 kg/m2
- •Meeting the Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D), defined as Bristol Stool Form Scale type 6 or 7 in 25% or more of bowel movements from 2 weeks before screening through the day of the screening visit
- •No inflammatory bowel disease or malignancy
- •Provided written agreement to refrain from consuming kimchi-containing foods for the duration of the study (approximately 2 months)
排除标准
- •Drug-induced constipation
- •Constipation secondary to another condition, such as diabetes mellitus or thyroid disease
- •History of intra-abdominal surgery other than appendectomy (including gastrectomy, gastric bypass, gallbladder or biliary tract surgery, pancreatectomy, bowel resection with particular reference to the ileum, and colorectal surgery or insertion procedures)
- •Uncontrolled hypertension (resting blood pressure 160/100 mmHg or higher)
- •Uncontrolled diabetes mellitus (fasting blood glucose 160 mg/dL or higher)
- •Uncontrolled hypothyroidism or hyperthyroidism
- •AST or ALT concentration 3 times or more the upper limit of the reference range of the testing laboratory
- •Creatinine concentration 2 times or more the upper limit of the reference range of the testing laboratory
- •Severe cardiovascular or cerebrovascular disease or malignancy within the previous 6 months
- •Psychiatric disorder such as severe affective disorder, schizophrenia, or substance use disorder, or current use of related psychiatric medication (intermittent use for sleep disturbance is permitted)
- •Severe alcohol use disorder
- •Heavy smoking (20 cigarettes per day or more)
- •Hypersensitivity to the main ingredient or components of the study food
- •Severe gastrointestinal symptoms such as heartburn or dyspepsia
- •Use of medications or foods that may affect the study results, including kimchi and probiotics
- •For female volunteers, suspected pregnancy, lactation, or plan to become pregnant during the study period
- •Participation in another drug clinical trial within one month prior to the screening date, or planned participation
- •Judged unsuitable for participation by the principal investigator for reasons other than those listed above
研究组 & 干预措施
This group takes Kimchi power for 8 weeks.
Participants take capsules containing kimchi powder, 3 capsules three times daily after breakfast, lunch, and dinner with water, for 8 weeks (56 days). Total daily intake is 3,600 mg/day (400 mg x 9 capsules), corresponding to 3,000 mg/day of kimchi powder.
干预措施: Kimchi power (Dietary Supplement)
This group takes placebo power for 8 weeks.
Participants take placebo capsules identical in appearance to the test product, containing lactose and other excipients, 3 capsules three times daily after breakfast, lunch, and dinner with water, for 8 weeks (56 days). Total daily intake is 3,600 mg/day (400 mg x 9 capsules).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in IBS Severity Scoring System (IBS-SSS) total score
时间窗: Baseline (Day 0) and Week 8 (Day 56 +/- 7)
The IBS Severity Scoring System (IBS-SSS) consists of five items assessing severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life. Each item is scored on a 100-point visual analogue scale, giving a total score ranging from 0 to 500. Higher scores indicate more severe symptoms; scores below 75 indicate remission, 75 to 175 mild, 175 to 300 moderate, and above 300 severe irritable bowel syndrome. Change is calculated as the Week 8 value minus the baseline value, with a negative change indicating improvement.
次要结局
- Change in stool form measured by the Bristol Stool Form Scale(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score(Baseline (Day 0), Week 3 (Day 21 +/- 7), and Week 8 (Day 56 +/- 7))
- Change in Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS) score(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in defecation symptom assessment (frequency of diarrhea)(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in serum interleukin-1 beta (IL-1beta) concentration(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in serum tumor necrosis factor alpha (TNF-alpha) concentration(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in serum immunoglobulin G (IgG) concentration(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in serum immunoglobulin A (IgA) concentration(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration(Baseline (Day 0) and Week 8 (Day 56 +/- 7))
- Change in fecal calprotectin(Baseline (Day 0), Week 3 (Day 21 +/- 7), and Week 8 (Day 56 +/- 7))
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital