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Oat Milk for Laxation

NCT ID: NCT07302542

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

oat milk

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oat milk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiuwen Ren

Doctoral Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Xiuwen Ren, PH.D.

Role: CONTACT

Phone: +86+17338155807

Email: [email protected]

Other Identifiers

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MNCGJH-20250903-0022

Identifier Type: -

Identifier Source: org_study_id