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

San Antonio Technologies - San Antonio Catholic University of Murcia

Status

Completed

Conditions

Constipation

Treatments

Other: placebo

Dietary Supplement: Resistant maltodextrins

Study type

Interventional

Funder types

Other

Identifiers

NCT01802112

PROT-001

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.