Functional ConstipationNCT01933100
Comparison of Rice Based-meal on Functional Constipation in Young Korean Women
A study testing Experimental Diet in people with Functional Constipation, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women. Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Experimental Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 19 to 30 years females
- Meet of Rome Ⅲ diagnostic criteria of functional constipation
- Ability to give informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods
Jeonju, Jeollabuk-do, 560-822
About this study
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
This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women.
Read the 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.
- Conditions
- Functional Constipation
- Being tested
- Experimental Diet
- Keywords
- Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Experimental Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total colon transit time
Hour of total colonic transit
Measured: 0, 28 days from the start of the study
Secondary outcomes (10)
Stool frequency
Frequency of stool(week)
Measured: 0, 28 days from the start of the study
Fecal weight
weight of fecal
Measured: 0, 28 days from the start of the study
Fecal pH
Fecal pH
Measured: 0, 28 days from the start of the study
Fecal lactic acid
Short chain fatty acid(lactic acid)
Measured: 0, 28 days from the start of the study
Fecal butyric acid
Short chain fatty acid
Measured: 0, 28 days from the start of the study
Fecal propionic acid
Short chain fatty acid
Measured: 0, 28 days from the start of the study
Fecal β-glucuronidase
Fecal enzyme
Measured: 0, 28 days from the start of the study
Fecal urease
Fecal enzyme
Measured: 0, 28 days from the start of the study
Fecal β-glucosidase
Fecal enzyme
Measured: 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
Measured: 28 days from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933100
- Sponsor's protocol ID
- CTCF2_2012_RP
- Status last verified
- Dec 2019
- First submitted
- 28 Aug 2013
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01933100
- Acronym / sponsor ID
- CTCF2_2012_RP
- Conditions
- Functional Constipation
- Keywords
- Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brown Rice Based-Meal | Experimental | Other: Experimental DietMacronutrient 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 |
| Polished Rice Based-Meal | Experimental | Other: Experimental DietMacronutrient 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 |
| Wheat Based-Meal | Experimental | Other: Experimental DietMacronutrient 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 |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 19 to 30 years females
- Meet of Rome Ⅲ diagnostic criteria of functional constipation
- Ability to give informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental DietMacronutrient 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 | Brown Rice Based-Meal, Polished Rice Based-Meal, Wheat Based-Meal |
Primary outcome
Total colon transit time
Time frame: 0, 28 days from the start of the study
Hour of total colonic transit
10 secondary outcomes
Stool frequency
Time frame: 0, 28 days from the start of the study
Fecal weight
Time frame: 0, 28 days from the start of the study
Fecal pH
Time frame: 0, 28 days from the start of the study
Fecal lactic acid
Time frame: 0, 28 days from the start of the study
Fecal butyric acid
Time frame: 0, 28 days from the start of the study
Fecal propionic acid
Time frame: 0, 28 days from the start of the study
Fecal β-glucuronidase
Time frame: 0, 28 days from the start of the study
Fecal urease
Time frame: 0, 28 days from the start of the study
Fecal β-glucosidase
Time frame: 0, 28 days from the start of the study
Bowel movement
Time frame: 28 days from the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Diet in people with Functional Constipation, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total colon transit time (time frame: 0, 28 days from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.