ConstipationNCT01802112
Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
A study testing Resistant maltodextrins in people with Constipation, run by San Antonio Technologies - San Antonio Catholic University of Murcia at 1 site in Spain.
Trial summary
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Resistant maltodextrins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Jun 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes (men and women) between 18 and 30 years old of Caucasian race selected from the general population
- Subjects capable of understanding the clinical study, willing to provide written informed consent and to fulfil the procedures and requirements of the study.
Who cannot join
- Diagnosis of a BMI ≥ 30 Kg/m2.
- Individuals with a daily defecation habit.
- Subjects with a history of any digestive disease or who have undergone gastrointestinal surgery (excluding appendicectomy or herniorrhaphy), abdominal surgery in the last two years or any recent major extra-abdominal surgery.
- Subjects with diabetes, hypothyroidism or hyperthyroidism.
- Subjects with a history of systemic disease that might effect gut motility.
- Subjects on dietary treatment and/or drugs that effect body weight or appetite.
Show all 16Show fewer
- Individuals that have had any change in dietary habit in the last 2 months.
- Subjects with a history of drug or alcohol abuse, or other substances or factors that might limit their ability to cooperate during the study.
- Subjects with bowel habits affected by stress.
- Subjects taking medication or drugs that alter gut motility.
- Pregnant women.
- Subjects that have stopped smoking in the last 6 months or who intend to give up smoking during the study.
- Subjects with allergies or eating disorders.
- Subjects that consume an excessive amount of alcohol (>3 glasses of wine or beer per day)
- Individuals that engage in physical exercise two or more times per week.
- Subjects whose condition makes them ineligible to take part in the study, according to the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.
Read the detailed description
In the last fifty years we have drastically changed our eating habits, in particular our fibre intake. Our hunter-gatherer ancestors ate more than 100 species of fruit and vegetables, which contributed between 20 and 30 g of dietary fibre per day. Currently, a typical citizen of our country reaches 10% of that amount.
Therefore, fibre deficiency alters digestion and metabolism, increasing nutrient absorption (obesity, increased insulin resistance, hyperlipidaemias), produces altered colonic metabolism (inflammatory bowel disease), and slows faecal transit (increasing the lumen pressure with diverticulosis, appendicitis, haemorrhoids and colon cancer. In addition, the prebiotic effect is important.
Several studies have demonstrated the effectiveness of digestion-resistant maltodextrin in the treatment of chronic idiopathic constipation. Investigators carried out a single blind study among young people with constipation who were administered 9.2 grams of resistant maltodextrins per day or placebo, and found significant changes in defecation frequency and in faecal volume.
Kimura et al. carried out a clinical trial in women with constipation and a defecation frequency of less than 3 times per week and administered 5 grams of resistant maltodextrins per day, demonstrating its effectiveness in significantly increasing the number of defecations per week, the number of days per week without defecation and the faecal volume. Additionally, an improvement was found aspects such as colour, stool odour and psychological feeling after defecation.
Finally, an interesting feature of Resistant maltodextrins is that it normalises the colonic transit time without causing diarrhoea, whilst increasing the stool volume, moisture and frequency of defecation.
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.
For That, 60 subjects will be stratified by gender (30 women: 15 with resistant maltodextrins and 15 placebo and 30 men: 15 with resistant maltodextrins and 15 placebo).
- Conditions
- Constipation
- Being tested
- Resistant maltodextrins, placebo
- Keywords
- Colonic transit, Dietary Fiber, Radiopaque marker
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant maltodextrinsDietary supplement
Also called Fibersol®
15 grams of Resistant maltodextrins per day dissolved in water during 21 days
placeboOther
15gr placebo
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrins | Placebo comparator | 15 grams of maltodextrins per day dissolved in water during 21 days Receives: Other: placebo |
| Resistant maltodextrins | Experimental | 15 grams of resistant maltodextrins per day, dissolved in water during 21 days Receives: Dietary Supplement: Resistant maltodextrins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Colonic Transit Time (CTT)
to determine CTT volunteers should ingest a capsule of radiopaque markers each day for five consecutive days. 24 hours after the final intake of markers an abdominal X-ray should be performed.
Measured: 28 days from the start of the study
Secondary outcomes (8)
Segmental colonic transit time (SCTT)
to determine CTT volunteers should ingest a capsule of radiopaque markers each day for five consecutive days. 24 hours after the final intake of markers an abdominal X-ray should be performed.
Measured: 28 days from the start of the study
Defecation frequency (DF)
Measured: 28 days
Stool Consistency
Each of the study subjects will be given a defecation habit diary where consistency of stools from the 28 days of the experimental phase will be recorded according to the Bristol Stool Chart
Measured: 28 days
Stool volume by just their eye observation
Measured: 28 days
Clinical Variables of Intestinal Function
these variables will be assessed by determining the number of the Rome III Criteria they fulfil
Measured: 28 days
Assessment of dietary fibre intake
This outcome will be assessed using a dietary survey. A five-day food record. This food record will be carried out at the same days in both study phases (from day 2 to day 6 and from day 23 to day 27).
This data will be processed by a computer system that uses internationally validated food composition tables
Measured: from day 2 to day 6 and from day 23 to day 27
Efficacy Blood analysis
A blood sample will be taken to determine the blood count and blood biochemistry (glucose, lipid profile, ferritin and ions).
Measured: 28 days
Safety Blood analysis
An analysis of blood biochemistry will be carried out to determine values for enzymes to assess liver function, and biomolecules such as bilirubin, urea and creatinine to assess renal function
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Antonio Technologies - San Antonio Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia, Hospital Virgen de la Vega
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802112
- Sponsor's protocol ID
- PROT-001
- Status last verified
- Apr 2018
- First submitted
- 22 Feb 2013
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
- ClinicalTrials.gov ID
- NCT01802112
- Acronym / sponsor ID
- PROT-001
- Conditions
- Constipation
- Keywords
- Colonic transit, Dietary Fiber, Radiopaque marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- San Antonio Technologies - San Antonio Catholic University of MurciaUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia, Hospital Virgen de la Vega
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Mar 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.
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.
Detailed description
In the last fifty years we have drastically changed our eating habits, in particular our fibre intake. Our hunter-gatherer ancestors ate more than 100 species of fruit and vegetables, which contributed between 20 and 30 g of dietary fibre per day. Currently, a typical citizen of our country reaches 10% of that amount.
Therefore, fibre deficiency alters digestion and metabolism, increasing nutrient absorption (obesity, increased insulin resistance, hyperlipidaemias), produces altered colonic metabolism (inflammatory bowel disease), and slows faecal transit (increasing the lumen pressure with diverticulosis, appendicitis, haemorrhoids and colon cancer. In addition, the prebiotic effect is important.
Several studies have demonstrated the effectiveness of digestion-resistant maltodextrin in the treatment of chronic idiopathic constipation. Investigators carried out a single blind study among young people with constipation who were administered 9.2 grams of resistant maltodextrins per day or placebo, and found significant changes in defecation frequency and in faecal volume.
Kimura et al. carried out a clinical trial in women with constipation and a defecation frequency of less than 3 times per week and administered 5 grams of resistant maltodextrins per day, demonstrating its effectiveness in significantly increasing the number of defecations per week, the number of days per week without defecation and the faecal volume. Additionally, an improvement was found aspects such as colour, stool odour and psychological feeling after defecation.
Finally, an interesting feature of Resistant maltodextrins is that it normalises the colonic transit time without causing diarrhoea, whilst increasing the stool volume, moisture and frequency of defecation.
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.
For That, 60 subjects will be stratified by gender (30 women: 15 with resistant maltodextrins and 15 placebo and 30 men: 15 with resistant maltodextrins and 15 placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrins | Placebo comparator | Other: placebo15 grams of maltodextrins per day dissolved in water during 21 days |
| Resistant maltodextrins | Experimental | Dietary Supplement: Resistant maltodextrins15 grams of resistant maltodextrins per day, dissolved in water during 21 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects of both sexes (men and women) between 18 and 30 years old of Caucasian race selected from the general population
- Subjects capable of understanding the clinical study, willing to provide written informed consent and to fulfil the procedures and requirements of the study.
Key exclusion criteria (16 listed)
- Diagnosis of a BMI ≥ 30 Kg/m2.
- Individuals with a daily defecation habit.
- Subjects with a history of any digestive disease or who have undergone gastrointestinal surgery (excluding appendicectomy or herniorrhaphy), abdominal surgery in the last two years or any recent major extra-abdominal surgery.
- Subjects with diabetes, hypothyroidism or hyperthyroidism.
- Subjects with a history of systemic disease that might effect gut motility.
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 |
|---|---|---|
| Resistant maltodextrinsAlso: Fibersol®15 grams of Resistant maltodextrins per day dissolved in water during 21 days | Dietary supplement | Resistant maltodextrins |
| placebo15gr placebo | Other | Maltodextrins |
Primary outcome
Changes in Colonic Transit Time (CTT)
Time frame: 28 days from the start of the study
to determine CTT volunteers should ingest a capsule of radiopaque markers each day for five consecutive days. 24 hours after the final intake of markers an abdominal X-ray should be performed.
8 secondary outcomes
Segmental colonic transit time (SCTT)
Time frame: 28 days from the start of the study
Defecation frequency (DF)
Time frame: 28 days
Stool Consistency
Time frame: 28 days
Stool volume by just their eye observation
Time frame: 28 days
Clinical Variables of Intestinal Function
Time frame: 28 days
Assessment of dietary fibre intake
Time frame: from day 2 to day 6 and from day 23 to day 27
Efficacy Blood analysis
Time frame: 28 days
Safety Blood analysis
Time frame: 29 days
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 19 Apr 2018.
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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 Resistant maltodextrins in people with Constipation, run by San Antonio Technologies - San Antonio Catholic University of Murcia at 1 site in Spain.
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 2 inclusion and 16 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 19 Apr 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Changes in Colonic Transit Time (CTT) (time frame: 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 19 Apr 2018.