NCT01933100

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

August 28, 2013

Last Update Submit

December 20, 2019

Conditions

Functional Constipation

Keywords

Functional constipationBrown rice based-mealPolished rice based-mealWheat based-meal

Outcome Measures

Primary Outcomes (1)

  • Total colon transit time

    Hour of total colonic transit

    0, 28 days from the start of the study

Secondary Outcomes (10)

  • Stool frequency

    0, 28 days from the start of the study

  • Fecal weight

    0, 28 days from the start of the study

  • Fecal pH

    0, 28 days from the start of the study

  • Fecal lactic acid

    0, 28 days from the start of the study

  • Fecal butyric acid

    0, 28 days from the start of the study

  • +5 more secondary outcomes

Study Arms (3)

Brown Rice Based-Meal

EXPERIMENTAL

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

Polished Rice Based-Meal

EXPERIMENTAL

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

Wheat Based-Meal

EXPERIMENTAL

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

Interventions

Experimental DietOTHER

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

Brown Rice Based-MealPolished Rice Based-MealWheat Based-Meal

Eligibility Criteria

Age19 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 19 to 30 years females
  • Meet of Rome Ⅲ diagnostic criteria of functional constipation
  • Ability to give informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)