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

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University of Copenhagen

Status

Completed

Conditions

Irritable Bowel

Treatments

Dietary Supplement: Barley β-glucan
Dietary Supplement: Control

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

56 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

56 participants in 2 patient groups, including a placebo group

Test drink
Experimental group
Description:
Test drink: Barley β-glucan
Treatment:
Dietary Supplement: Barley β-glucan
Control drink
Placebo Comparator group
Description:
Control drink: barley beverage
Treatment:
Dietary Supplement: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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