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

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

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

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Other: Experimental Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brown Rice Based-Meal; 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	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
Experimental: Polished Rice Based-Meal; 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	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
Experimental: Wheat Based-Meal; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total colon transit time	Hour of total colonic transit	0, 28 days from the start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Frequency of stool(week)	0, 28 days from the start of the study
Fecal weight	weight of fecal	0, 28 days from the start of the study
Fecal pH	Fecal pH	0, 28 days from the start of the study
Fecal lactic acid	Short chain fatty acid(lactic acid)	0, 28 days from the start of the study
Fecal butyric acid	Short chain fatty acid	0, 28 days from the start of the study
Fecal propionic acid	Short chain fatty acid	0, 28 days from the start of the study
Fecal β-glucuronidase	Fecal enzyme	0, 28 days from the start of the study
Fecal urease	Fecal enzyme	0, 28 days from the start of the study
Fecal β-glucosidase	Fecal enzyme	0, 28 days from the start of the study
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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Functional constipation; Brown rice based-meal; Polished rice based-meal; Wheat based-meal
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: CTCF2_2012_RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No