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

Not Applicable

Completed

• Conditions: Functional Constipation
• Interventions: Other: Experimental Diet

• Registration Number: NCT01933100
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-02
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polished Rice Based-Meal	Experimental Diet	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
Wheat Based-Meal	Experimental Diet	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
Brown Rice Based-Meal	Experimental Diet	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

Primary Outcome Measures

Name	Time	Method
Total colon transit time	0, 28 days from the start of the study	Hour of total colonic transit

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of