Skip to main content
OpenTrials
Completed

NCT Number: NCT03046667

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: barley beta-glucan beverages

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

Other names: barley drink

Primary outcomes

  1. Stool volume

    Time frame: 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 outcomes

  1. Hydrogen

    Time frame: 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.

  2. Methane

    Time frame: 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.

  3. Hydrogen Area Under the Curve

    Time frame: -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

  4. Methane Area Under the Curve

    Time frame: -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

  5. Fecal concentrations of SCFA

    Time frame: 0 and 6 weeks

    Changes in SCFA concentrations determined by a mixed model analysis

  6. Determination and variations in fecal microbiota

    Time frame: 0 and 6 weeks

    Changes in microbiota determined by a mixed model analysis

  7. Fecal concentrations of calprotectin

    Time frame: 0 and 6 weeks

    Changes in calprotectin concentrations determined by a mixed model analysis

Other outcomes

  1. Metabolic profile in 24h urine collections

    Time frame: 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)

  2. Metabolic profile in 3d fecal collections

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Carlsberg Group

Registry information

Acronym: NEWDRINK

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2017
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.