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

NCT ID: NCT03046667

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2017-12-11

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.

Conditions

Irritable Bowel

Keywords

Beta glucans; Barley; SCFA; Calprotectin; Microbiota; Hydrogene; Methane; Metabolomics; Stool volume; Stool frequency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test drink

Test drink: Barley β-glucan

Group Type: EXPERIMENTAL

Barley β-glucan

Intervention Type: DIETARY_SUPPLEMENT

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.

Control drink

Control drink: barley beverage

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

barley beta-glucan beverages; barley drink

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carlsberg Group

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Professor Lars Ove Dragsted

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Ove Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, , Denmark

Countries

Denmark

Other Identifiers

M230

Identifier Type: -

Identifier Source: org_study_id