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

Not Applicable

Completed

• Conditions: Irritable Bowel
• Interventions: Dietary Supplement: Barley β-glucan; Dietary Supplement: Control

• Registration Number: NCT03046667
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-05
• Study Start: 2017-02-08
• Study First Posted: 2017-02-08
• Primary Completion: 2017-07-20
• Status Verified: 2017-12
• Study Completion: 2017-12-11
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test drink	Barley β-glucan	Test drink: Barley β-glucan
Control drink	Control	Control drink: barley beverage

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Fecal concentrations of SCFA	0 and 6 weeks	Changes in SCFA concentrations determined by a mixed model analysis
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
Determination and variations in fecal microbiota	0 and 6 weeks	Changes in microbiota determined by a mixed model analysis
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.
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
Fecal concentrations of calprotectin	0 and 6 weeks	Changes in calprotectin concentrations determined by a mixed model analysis

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen; 🇩🇰 Frederiksberg, Denmark