Status:
COMPLETED
Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
Lead Sponsor:
San Antonio Technologies - San Antonio Catholic University of Murcia
Collaborating Sponsors:
Universidad Católica San Antonio de Murcia
Hospital Virgen de la Vega
Conditions:
Constipation
Eligibility:
All Genders
18-30 years
Phase:
NA
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 contribute...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01802112
Start Date
February 1 2013
End Date
June 1 2013
Last Update
April 19 2018
Active Locations (1)
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1
San Antonio Catholic University of Murcia
Guadalupe, Murcia, Spain, 30107