Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01802112
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).
Study:
NCT01802112
Study Brief:
Protocol Section:
NCT01802112