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

NCT ID: NCT01933100

Last Updated: 2019-12-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-08-31

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.

Conditions

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Functional Constipation

Keywords

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Functional constipation Brown rice based-meal Polished rice based-meal Wheat based-meal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Brown Rice Based-Meal

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

Group Type EXPERIMENTAL

Experimental Diet

Intervention Type OTHER

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

Polished Rice Based-Meal

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

Group Type EXPERIMENTAL

Experimental Diet

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Experimental Diet

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CTCF2_2012_RP

Identifier Type: -

Identifier Source: org_study_id