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

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT03046667

Collaborator

Carlsberg Group (Other)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel	Dietary Supplement: Barley β-glucan Dietary Supplement: Control	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 8, 2017

Actual Primary Completion Date :

Jul 20, 2017

Actual Study Completion Date :

Dec 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test drink Test drink: Barley β-glucan	Dietary Supplement: Barley 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. Other Names: barley beta-glucan beverages
Placebo Comparator: Control drink Control drink: barley beverage	Dietary Supplement: 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 Other Names: barley drink

Arm

Intervention/Treatment

Experimental: Test drink

Test drink: Barley β-glucan

Dietary Supplement: Barley 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.

Other Names:

barley beta-glucan beverages

Placebo Comparator: Control drink

Control drink: barley beverage

Dietary Supplement: 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

Other Names:

barley drink

Outcome Measures

Primary Outcome Measures

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

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
Fecal concentrations of SCFA [0 and 6 weeks]
Changes in SCFA concentrations determined by a mixed model analysis
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

Other Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.