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Not yet recruiting NCT07302542

Oat Milk for Laxation

No phase Interventional Constipation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oat milk.
Who it may be relevant to
Registry conditions: Constipation. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing [Time frame: Collect feces and evaluate at baseline and at the fourth week.]
Secondary outcome measures (1)
  • Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale [Time frame: Participates will fill out the questionnaire at baseline, Week 2, and Week 4.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07302542 · MNCGJH-20250903-0022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗