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

NCT03046667 | Completed

• 1 other identifier: M230
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hydrogen

  0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min

• Methane

  0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min

• Hydrogen Area Under the Curve

  -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min

• Methane Area Under the Curve

  -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min

• Fecal concentrations of SCFA

  0 and 6 weeks

Other Outcomes (2)

• Metabolic profile in 24h urine collections

  0 and 6 weeks

• Metabolic profile in 3d fecal collections

  0 and 6 weeks

Study Arms (2)

Test drink

EXPERIMENTAL

Test drink: Barley β-glucan

Dietary Supplement: Barley β-glucan

Control drink

PLACEBO COMPARATOR

Control drink: barley beverage

Dietary Supplement: Control

Interventions

Barley β-glucan 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.

Also known as: barley beta-glucan beverages

Test drink

Control 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

Also known as: barley drink

Control drink

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Carlsberg Group: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Lars Ove Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: February 8, 2017
• Primary Completion: July 20, 2017
• Study Completion: December 11, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 24 months from completion
• Access Criteria: Full access to published, anonymized data

Locations

DK (1)