Clinical trial NCT03046667: Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Official title: Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel
Keywords: Beta glucans
Barley
SCFA
Calprotectin
Microbiota
Hydrogene
Methane
Metabolomics
Stool volume
Stool frequency
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Carlsberg Group
First posted: 2017-02-08
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stool volume
timeFrame: 0 and 6 weeks
Secondary outcomes:
measure: Hydrogen
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
measure: Methane
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
measure: Hydrogen Area Under the Curve
timeFrame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
measure: Methane Area Under the Curve
timeFrame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
measure: Fecal concentrations of SCFA
timeFrame: 0 and 6 weeks
measure: Determination and variations in fecal microbiota
timeFrame: 0 and 6 weeks
measure: Fecal concentrations of calprotectin
timeFrame: 0 and 6 weeks
Other outcomes:
measure: Metabolic profile in 24h urine collections
timeFrame: 0 and 6 weeks
measure: Metabolic profile in 3d fecal collections
timeFrame: 0 and 6 weeks
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Lars Ove Dragsted, PhD
role: PRINCIPAL_INVESTIGATOR
References: