Oat Milk for Laxation

NCT07302542 | Not Yet Recruiting

• 1 other identifier: MNCGJH-20250903-0022
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale

  Participates will fill out the questionnaire at baseline, Week 2, and Week 4.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Dietary Supplement: oat milk

Control Group

NO INTERVENTION

Interventions

oat milk DIETARY_SUPPLEMENT

The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 28 consecutive days

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of non-organic and habitual constipation;
• Reduced defecation frequency;
• Increased stool hardness;
• Fewer than 4 bowel movements per week;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiuwen Ren, PH.D.

CONTACT

+86+17338155807; renxiuwen@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 24, 2025
• Study Start: December 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share