Comparison of Rice Based-meal on Functional Constipation in Young Korean Women

Study Overview
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Brief Summary
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This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women.

Detailed Description
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Studies comparing and evaluating the effects of a rice-based diet and a wheat-based diet on bowel movements are insufficient. In summary, efficient measures are needed to help individuals consume enough dietary fiber from natural sources in daily life to improve their bowel movements, rather than to consume a fiber supplements separated or synthesized from a particular natural food. In this study, investigators compare and evaluate the effects and safety of eating rice-based diets (brown rice-based and white rice-based) and a wheat-based diet in terms of bowel health and bowel movements among young women with functional constipation.

Official Title
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Comparison of Brown Rice Based-meal or Polished Rice Based-meal or Wheat Based-meal on Functional Constipation in Young Korean Women: A Opened, Clinical Trial

Conditions
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Functional Constipation

Intervention / Treatment
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* Other: Experimental Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 19 to 30 years females Meet of Rome Ⅲ diagnostic criteria of functional constipation Ability to give informed consent Exclusion Criteria: Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN) Subjects with significant hypersensitivity about brown rice, polished rice, wheat, milk Regular ingestion of probiotic products Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration Subjects who participated in other clinical investigation within 2 months prior to first administration Subject who drink constantly (21 units/week over) Subject who are pregnant or breast feeding Subject who have irritable bowel syndrome by ROME Ⅲ criteria Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study(i.e., laboratory test and others)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brown Rice Based-Meal<br>Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women | Other: Experimental Diet<br>* Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women<br>|
| Experimental: Polished Rice Based-Meal<br>Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women | Other: Experimental Diet<br>* Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women<br>|
| Experimental: Wheat Based-Meal<br>Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women | Other: Experimental Diet<br>* Macronutrient composition of experimental diet were carbohydrate 55 70%, protein 7 20%, fat 15 25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total colon transit time | Hour of total colonic transit | 0, 28 days from the start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency | Frequency of stool(week) | 0, 28 days from the start of the study | 
| Fecal weight | weight of fecal | 0, 28 days from the start of the study | 
| Fecal pH | Fecal pH | 0, 28 days from the start of the study | 
| Fecal lactic acid | Short chain fatty acid(lactic acid) | 0, 28 days from the start of the study | 
| Fecal butyric acid | Short chain fatty acid | 0, 28 days from the start of the study | 
| Fecal propionic acid | Short chain fatty acid | 0, 28 days from the start of the study | 
| Fecal β-glucuronidase | Fecal enzyme | 0, 28 days from the start of the study | 
| Fecal urease | Fecal enzyme | 0, 28 days from the start of the study | 
| Fecal β-glucosidase | Fecal enzyme | 0, 28 days from the start of the study | 
| Bowel movement | The bowel movement questionnire includes the defecation frequency, bowel time, fecal color, degree of difficulty in defecation and abdominal symptom | 28 days from the start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal