Functional Constipation
Conditions
Keywords
Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal
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.
Interventions
OTHERExperimental 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
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 30 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total colon transit time | 0, 28 days from the start of the study | Hour of total colonic transit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal weight | 0, 28 days from the start of the study | weight of fecal |
| Fecal pH | 0, 28 days from the start of the study | Fecal pH |
| Fecal lactic acid | 0, 28 days from the start of the study | Short chain fatty acid(lactic acid) |
| Fecal butyric 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 β-glucuronidase | 0, 28 days from the start of the study | Fecal enzyme |
| 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 |
| 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 |
| Fecal propionic acid | 0, 28 days from the start of the study | Short chain fatty acid |
Countries
South Korea
Outcome results
None listed