An interventional study of Resistant maltodextrins and placebo in Constipation, sponsored by San Antonio Technologies - San Antonio Catholic University of Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by San Antonio Technologies - San Antonio Catholic University of Murcia · Not applicable, Interventional, and Treatment
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.
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).
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with San Antonio Technologies - San Antonio Catholic University of Murcia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15 grams of maltodextrins per day dissolved in water during 21 days
Other: placebo
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
Also known as: Fibersol®
15gr placebo
Changes in Colonic Transit Time (CTT)
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.
Time frame: 28 days from the start of the study
Segmental colonic transit time (SCTT)
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.
Time frame: 28 days from the start of the study
Defecation frequency (DF)
Time frame: 28 days
Stool Consistency
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
Time frame: 28 days
Stool volume by just their eye observation
Time frame: 28 days
Clinical Variables of Intestinal Function
these variables will be assessed by determining the number of the Rome III Criteria they fulfil
Time frame: 28 days
Assessment of dietary fibre intake
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
Time frame: from day 2 to day 6 and from day 23 to day 27
Efficacy Blood analysis
A blood sample will be taken to determine the blood count and blood biochemistry (glucose, lipid profile, ferritin and ions).
Time frame: 28 days
Safety Blood analysis
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
Time frame: 29 days
Adverse Events
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.
Time frame: 29 days
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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