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

Functional Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933100
• Other study ID #: CTCF2_2012_RP
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 30 Years

Eligibility

Inclusion Criteria:

• Age of 19 to 30 years females

• Meet of Rome ? 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 ? 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)

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Other:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total colon transit time	Hour of total colonic transit	0, 28 days from the start of the study
Secondary	Stool frequency	Frequency of stool(week)	0, 28 days from the start of the study
Secondary	Fecal weight	weight of fecal	0, 28 days from the start of the study
Secondary	Fecal pH	Fecal pH	0, 28 days from the start of the study
Secondary	Fecal lactic acid	Short chain fatty acid(lactic acid)	0, 28 days from the start of the study
Secondary	Fecal butyric acid	Short chain fatty acid	0, 28 days from the start of the study
Secondary	Fecal propionic acid	Short chain fatty acid	0, 28 days from the start of the study
Secondary	Fecal ß-glucuronidase	Fecal enzyme	0, 28 days from the start of the study
Secondary	Fecal urease	Fecal enzyme	0, 28 days from the start of the study
Secondary	Fecal ß-glucosidase	Fecal enzyme	0, 28 days from the start of the study
Secondary	Bowel movement	The bowel movement questionnire includes the defecation frequency, bowel time, fecal color, degree of difficulty in defecation and abdominal symptom	28 days from the start of the study