Oat Milk for Laxation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: oat milk

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuwen Ren, PH.D.; Phone Number: +86+17338155807; Email: renxiuwen@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Clinical diagnosis of non-organic and habitual constipation;

Reduced defecation frequency;

Increased stool hardness;

Fewer than 4 bowel movements per week;

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Dietary supplement: oat milk; The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 28 consecutive days
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing	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.	Collect feces and evaluate at baseline and at the fourth week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale	Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS, 15 items; score range: 1-7, with higher scores indicating more severe symptoms). Assessments will be conducted at baseline, Week 2, and Week 4. Symptoms include reflux, abdominal pain, indigestion, diarrhea, and constipation.	Participates will fill out the questionnaire at baseline, Week 2, and Week 4.

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation
• Other Study ID Numbers: MNCGJH-20250903-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No