Clinical trial NCT01933100: Comparison of Rice Based-meal on Functional Constipation in Young Korean Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: Functional constipation
Brown rice based-meal
Polished rice based-meal
Wheat based-meal
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 39
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total colon transit time
timeFrame: 0, 28 days from the start of the study
Secondary outcomes:
measure: Stool frequency
timeFrame: 0, 28 days from the start of the study
measure: Fecal weight
timeFrame: 0, 28 days from the start of the study
measure: Fecal pH
timeFrame: 0, 28 days from the start of the study
measure: Fecal lactic acid
timeFrame: 0, 28 days from the start of the study
measure: Fecal butyric acid
timeFrame: 0, 28 days from the start of the study
measure: Fecal propionic acid
timeFrame: 0, 28 days from the start of the study
measure: Fecal β-glucuronidase
timeFrame: 0, 28 days from the start of the study
measure: Fecal urease
timeFrame: 0, 28 days from the start of the study
measure: Fecal β-glucosidase
timeFrame: 0, 28 days from the start of the study
measure: Bowel movement
timeFrame: 28 days from the start of the study
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods
state: Jeollabuk-do
Study officials:
References: