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

Chonbuk National University

Status: Completed

Conditions: Functional Constipation

Treatments: Other: Experimental Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01933100

CTCF2_2012_RP

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 19 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Brown Rice Based-Meal

Experimental group

Description:

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

Treatment:

Other: Experimental Diet

Polished Rice Based-Meal

Experimental group

Description:

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

Treatment:

Other: Experimental Diet

Wheat Based-Meal

Experimental group

Description:

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

Treatment:

Other: Experimental Diet