Oat Milk for Laxation

Официальное название

Impact of Oat Milk Consumption on Gastrointestinal Transit and Defecation Frequency: A Controlled Intervention Trial in Adults

Обзор

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.

Вмешательства

• Пищевая добавка oat milk
  The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 28 consecutive days

Первичные конечные точки

• Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing [Срок оценки: Collect feces and evaluate at baseline and at the fourth week.]

Вторичные конечные точки (1)

• Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale [Срок оценки: Participates will fill out the questionnaire at baseline, Week 2, and Week 4.]

Критерии участия

Критерии включения

Clinical diagnosis of non-organic and habitual constipation;

Reduced defecation frequency;

Increased stool hardness;

Fewer than 4 bowel movements per week;

Критерии исключения

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.

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07302542 · MNCGJH-20250903-0022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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