Irritable Bowel
Conditions
Keywords
Beta glucans, Barley, SCFA, Calprotectin, Microbiota, Hydrogene, Methane, Metabolomics, Stool volume, Stool frequency
Brief summary
The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS). Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed
Detailed description
β-glucans from barley slows gastric emptying rate and prolongs the transit time of food in the small intestine. The relatively undigested β-glucans have the ability to increase satiety and stimulate digestion, ensuring regular bowel movements and relieve sluggish bowel movements, including constipation and constipation. β-glucans are fermented down in the large intestine, resulting in production of short-chain fatty acids which inhibit the biosynthesis of cholesterol, hence blood cholesterol levels are lowered (not the goal here). Subsequently, β-glucans may also affect blood pressure. As a direct result of the effects in the intestine, there will be an improvement in the quality of life for people with stomach upsets and maybe a reduction in the risk of cardiovascular disease.
Interventions
DIETARY_SUPPLEMENTBarley β-glucan
The test beverages with Barley β-glucan is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks consumed for 5 weeks. In total was the test drinks consumed for 6 weeks.
DIETARY_SUPPLEMENTControl
The control beverages is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks
Sponsors
Carlsberg Group
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 20 - 27 kg/m2 * Like test and control drink, pasta, meat sauce as these foods are part of the test meal. * Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation * Willing to handle in 2 x 3-day total feces at the start and end of the study
Exclusion criteria
* Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD). * Systemic infections, psychiatric or metabolic diseases, and any clinical condition * Chronic or frequent use of medication (including blood thinners, excluding contraceptives) * Frequent loose stools * Blood donations during or in the month leading up to the study period * Elite athletes (\> 10 hours of hard exercise / week, self-reported) * High intake of alcohol (defined as a weekly intake of \> 7 units for women and \> 14 units for men), * Have or have had a drug addiction * Participation in other scientific studies during the study period * Lactating * Pregnancy or ongoing planning of pregnancy * Vegetarianism or veganism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool volume | 0 and 6 weeks | Changes in total stool weight 2 x 3 days from 72 hours before study start and 72 hours before study termination after 6 weeks, determined by a mixed model analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hydrogen | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate. |
| Methane | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate. |
| Hydrogen Area Under the Curve | -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | Area Under the Curve (AUC) for exhaled hydrogen |
| Methane Area Under the Curve | -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | Area Under the Curve (AUC) for exhaled methane |
| Determination and variations in fecal microbiota | 0 and 6 weeks | Changes in microbiota determined by a mixed model analysis |
| Fecal concentrations of calprotectin | 0 and 6 weeks | Changes in calprotectin concentrations determined by a mixed model analysis |
| Fecal concentrations of SCFA | 0 and 6 weeks | Changes in SCFA concentrations determined by a mixed model analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolic profile in 24h urine collections | 0 and 6 weeks | Untargeted metabolic profile of urine samples measured in all samples collected 24 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 24 hours before study termination. The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) |
| Metabolic profile in 3d fecal collections | 0 and 6 weeks | Untargeted metabolic profile of fecal samples measured in all samples collected 72-0 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 72-0 hours before study termination. The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) |
Countries
Denmark
Outcome results
None listed