Clinical trial NCT01802112: Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
Official title: Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Colonic transit
Dietary Fiber
Radiopaque marker
Lead sponsor: San Antonio Technologies - San Antonio Catholic University of Murcia
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
name: Hospital Virgen de la Vega
First posted: 2013-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Changes in Colonic Transit Time (CTT)
timeFrame: 28 days from the start of the study
Secondary outcomes:
measure: Segmental colonic transit time (SCTT)
timeFrame: 28 days from the start of the study
measure: Defecation frequency (DF)
timeFrame: 28 days
measure: Stool Consistency
timeFrame: 28 days
measure: Stool volume by just their eye observation
timeFrame: 28 days
measure: Clinical Variables of Intestinal Function
timeFrame: 28 days
measure: Assessment of dietary fibre intake
timeFrame: from day 2 to day 6 and from day 23 to day 27
measure: Efficacy Blood analysis
timeFrame: 28 days
measure: Safety Blood analysis
timeFrame: 29 days
Other outcomes:
measure: Adverse Events
timeFrame: 29 days
Locations:
city: Guadalupe
country: Spain
facility: San Antonio Catholic University of Murcia
state: Murcia
Study officials:
References: