Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
Recruitment status was: Recruiting
|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|
- 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.
- 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
- 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.
|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)|
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®
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802112
|San Antonio Catholic University of Murcia|
|Guadalupe, Murcia, Spain, 30107|