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

Irritable Bowel Clinical Trial

— NEWDRINK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046667
• Other study ID #: M230
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: December 11, 2017
• Start date: February 8, 2017
• Est. completion date: December 11, 2017

Study information

• Verified date: December 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 11, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Barley ß-glucan
The test beverages with Barley ß-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.
• Control
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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Carlsberg Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic profile in 24h urine collections	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)	0 and 6 weeks
Other	Metabolic profile in 3d fecal collections	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)	0 and 6 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fecal concentrations of SCFA	Changes in SCFA concentrations determined by a mixed model analysis	0 and 6 weeks
Secondary	Determination and variations in fecal microbiota	Changes in microbiota determined by a mixed model analysis	0 and 6 weeks
Secondary	Fecal concentrations of calprotectin	Changes in calprotectin concentrations determined by a mixed model analysis	0 and 6 weeks