Oat Milk for Laxation

ConditionConstipation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • oat milk

    Dietary supplement

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
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

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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