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

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.

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)