Effects of Postbiotics on Mood Disorders in Korean Adults: Eight Week, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo
研究概览
简要总结
This study was conducted to investigate effects of postbiotics on mood disorders in korean adults
详细描述
This study is an 8-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial. 52 participants were randomly assigned to either the postbiotics intervention group or a placebo group. The study aimed to evaluate the effects of postbiotics on mood disorders in Korean adults, comparing pre- and post-intervention mood profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 19 and 39 years at the time of screening.
- •BMI between 18.5 and 30 at the time of screening.
- •CES-D (Center for Epidemiologic Studies Depression Scale) score of 16 or higher.
- •Ability to access and respond to the survey via an online link.
排除标准
- •Participation in any human clinical trial within the past 3 months before screening.
- •History of antipsychotic medication treatment within the past 3 months before screening.
- •Presence of chronic diseases, including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urological, neurological, musculoskeletal, inflammatory, hematological, oncological, or gastrointestinal disorders.
- •Use of medications or health supplements related to gut health and mood disorders (e.g., antibiotics, laxatives, antidiarrheals, prebiotics, probiotics, postbiotics, anxiolytics, antidepressants, etc.) within 1 month prior to participation in the study.
- •History of significant hypersensitivity to postbiotics or starch.
- •Alcohol addiction, drug abuse, or suspicion of substance misuse.
- •Pregnant or breastfeeding women.
- •Any other reasons that the study investigator deems the participant unsuitable for participation.
研究组 & 干预措施
postbiotics
3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks
干预措施: postbiotics (Dietary Supplement)
Placebo
3 capsules/day placebo for 8 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo
时间窗: week 0, week 8
Epidemiology Research Center Depression Scale (CES-D): The Center for Epidemiologic Studies Depression Scale (CES-D) is a widely used 20-item self-reported instrument designed to measure depressive symptom severity in the general population. Each item is rated on a 4-point scale (0 to 3), assessing emotional, somatic, interpersonal, and positive affect domains over the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.
Effect of postbiotics on momentary mood measured by Ecological Momentary Assessment (EMA), compared with placebo
时间窗: Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)
Ecological Momentary Assessment (EMA) captures real-time mood states by sending brief questionnaires to participants multiple times per day via online links. Each assessment includes six questions related to current mood and mental state, scored on a continuous slider scale from 0 (not at all) to 100 (very much). Higher scores indicate greater severity of negative mood or emotional distress. The average daily score will be calculated and used to assess change from baseline.
Effect of postbiotics on psychological distress measured by the Depression Anxiety Stress Scale-21 (DASS-21), compared with placebo
时间窗: week 0, week 8
The Depression Anxiety Stress Scale (DASS-21) is a validated self-report tool containing 21 items, divided equally into three subscales: depression, anxiety, and stress. Each item is rated on a 4-point scale (0 to 3), and subscale scores are summed. Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms in the respective domain.
次要结局
- Effect of postbiotics on perceived stress measured by the Perceived Stress Scale (PSS), compared with placebo(Week 0, Week 8)
- Effect of postbiotics on fecal microbiome composition, compared with placebo(Week 0, Week 8)
- Effect of postbiotics on fecal metabolites, compared with placebo(Week 0, Week 8)
- Effect of postbiotics on gastrointestinal symptoms measured by the Irritable Bowel Syndrome Visual Analog Scale (VAS-IBS), compared with placebo(Weekly from Week 0 to Week 8)
研究者
Yongsoon Park
Professor
Hanyang University