Impact of Oat Milk Consumption on Gastrointestinal Transit and Defecation Frequency: A Controlled Intervention Trial in Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing
研究概览
简要总结
This study intends to recruit 90-100 constipated participants aged 25-50 years, including an equal number of males and females, from the faculty and logistics staff of Capital Medical University. Participants will be randomly divided into an intervention group (55-60 individuals) and a control group (35-40 individuals). The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 4 weeks, while the control group will not receive oat milk intervention. Both groups will maintain their original lifestyles, including diet, sleep, and exercise, throughout the study period. Baseline surveys, dietary surveys, blood and urine routine tests, blood biochemical indices, and intestinal flora detection will be conducted before and after the intervention. Defecation status will be recorded, and gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Rating Scale. Statistical analysis will be performed to determine the laxative efficacy of oat milk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of non-organic and habitual constipation;
- •Reduced defecation frequency;
- •Increased stool hardness;
- •Fewer than 4 bowel movements per week;
排除标准
- •Inability to take food orally or inability to comply with the required intake of the test product;
- •Known allergy to oats or related products;
- •Unclear primary gastrointestinal complaints;
- •Physical weakness that prevents participation in the trial;
- •History of surgery within the past 30 days that may cause constipation；
- •Recent constipation caused by severe organic gastrointestinal lesions (e.g., colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease);
- •Constipation accompanied by significant abdominal pain;
- •Acute gastrointestinal diseases within the past 30 days;
- •Severe systemic diseases involving the cardiovascular, hepatic, renal, or hematopoietic systems;
- •Ongoing treatment for comorbid conditions that may interfere with study participation;
- •Recent use of substances related to the tested function that may influence outcome measurements.
结局指标
主要结局
Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing
时间窗: Collect feces and evaluate at baseline and at the fourth week.
Fecal samples from a randomly selected subgroup (30 participants in the intervention group and 15 in the control group) will be collected before and after the intervention. Metagenomic sequencing will be used to evaluate changes in intestinal microbiota composition and functional gene pathways, including metabolism-, immunity-, and disease-related gene sets. This outcome explores potential mechanisms by which the intervention exerts laxative effects.
次要结局
- Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale(Participates will fill out the questionnaire at baseline, Week 2, and Week 4.)
研究者
Xiuwen Ren
Doctoral Student
Capital Medical University