Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by San Antonio Technologies - San Antonio Catholic University of Murcia
Sponsor:
Collaborators:
Universidad Católica San Antonio de Murcia
Hospital Virgen de la Vega
Information provided by (Responsible Party):
San Antonio Technologies - San Antonio Catholic University of Murcia
ClinicalTrials.gov Identifier:
NCT01802112
First received: February 22, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Constipation
Dietary Supplement: Resistant maltodextrins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time

Resource links provided by NLM:


Further study details as provided by San Antonio Technologies - San Antonio Catholic University of Murcia:

Primary Outcome Measures:
  • Changes in Colonic Transit Time (CTT) [ Time Frame: 28 days from the start of the study ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Segmental colonic transit time (SCTT) [ Time Frame: 28 days from the start of the study ] [ Designated as safety issue: No ]
    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.

  • Defecation frequency (DF) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Stool Consistency [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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

  • Stool volume by just their eye observation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Clinical Variables of Intestinal Function [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    these variables will be assessed by determining the number of the Rome III Criteria they fulfil

  • Assessment of dietary fibre intake [ Time Frame: from day 2 to day 6 and from day 23 to day 27 ] [ Designated as safety issue: No ]

    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


  • Efficacy Blood analysis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    A blood sample will be taken to determine the blood count and blood biochemistry (glucose, lipid profile, ferritin and ions).

  • Safety Blood analysis [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Adverse Events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    The safety profile will be assessed using the record of adverse events. Adverse events related to this study will be due to the intake of soluble fibre, the most frequently reported being: flatulence, diarrhoea and gastrointestinal bloating.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Maltodextrins
15 grams of maltodextrins per day dissolved in water during 21 days
Experimental: Resistant maltodextrins
15 grams of resistant maltodextrins per day, dissolved in water during 21 days
Dietary Supplement: Resistant maltodextrins
15 grams of Resistant maltodextrins per day dissolved in water during 21 days
Other Name: Fibersol®

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802112

Contacts
Contact: Javier López Román, MD, PhD 34 968278523 jlroman@ucam.edu

Locations
Spain
San Antonio Catholic University of Murcia Recruiting
Guadalupe, Murcia, Spain, 30107
Contact: Javier López Román, MD, PhD    34 968278523    jlroman@ucam.edu   
Principal Investigator: Javier López Román, MD, PhD         
Sponsors and Collaborators
San Antonio Technologies - San Antonio Catholic University of Murcia
Universidad Católica San Antonio de Murcia
Hospital Virgen de la Vega
  More Information

No publications provided

Responsible Party: San Antonio Technologies - San Antonio Catholic University of Murcia
ClinicalTrials.gov Identifier: NCT01802112     History of Changes
Other Study ID Numbers: PROT-001
Study First Received: February 22, 2013
Last Updated: February 27, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by San Antonio Technologies - San Antonio Catholic University of Murcia:
Colonic transit
Dietary Fiber
Radiopaque marker

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014