Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health

Conditions
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Irritable Bowel

Intervention / Treatment
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* Dietary Supplement: Barley β-glucan
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test drink<br>Test drink: Barley β-glucan | Dietary Supplement: Barley β-glucan<br>* 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.<br>* Other names: barley beta-glucan beverages;|
| Placebo Comparator: Control drink<br>Control drink: barley beverage | Dietary Supplement: Control<br>* 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<br>* Other names: barley drink;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool volume | 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. | 0 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrogen | Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate. | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | 
| Methane | Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate. | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | 
| Hydrogen Area Under the Curve | Area Under the Curve (AUC) for exhaled hydrogen | -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | 
| Methane Area Under the Curve | Area Under the Curve (AUC) for exhaled methane | -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min | 
| Fecal concentrations of SCFA | Changes in SCFA concentrations determined by a mixed model analysis | 0 and 6 weeks | 
| Determination and variations in fecal microbiota | Changes in microbiota determined by a mixed model analysis | 0 and 6 weeks | 
| Fecal concentrations of calprotectin | Changes in calprotectin concentrations determined by a mixed model analysis | 0 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta glucans, Barley, SCFA, Calprotectin, Microbiota, Hydrogene, Methane, Metabolomics, Stool volume, Stool frequency