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Trial record 10 of 54 for:    barley

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

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ClinicalTrials.gov Identifier: NCT03046667
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Carlsberg Group
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

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


Condition or disease Intervention/treatment Phase
Irritable Bowel Dietary Supplement: Barley β-glucan Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.
Primary Purpose: Prevention
Official Title: Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : December 11, 2017

Arm Intervention/treatment
Experimental: Test drink
Test drink: Barley β-glucan
Dietary Supplement: 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.
Other Name: barley beta-glucan beverages

Placebo Comparator: Control drink
Control drink: barley beverage
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
Other Name: barley drink




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046667


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Carlsberg Group
Investigators
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Principal Investigator: Lars Ove Dragsted, PhD University of Copenhagen

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Responsible Party: Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03046667     History of Changes
Other Study ID Numbers: M230
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After full anonymization the data may be shared pending acceptance by sponsor approximately 24 months after completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: 24 months from completion
Access Criteria: Full access to published, anonymized data
URL: https://enpadasi.science.ku.dk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Lars Ove Dragsted, University of Copenhagen:
Beta glucans
Barley
SCFA
Calprotectin
Microbiota
Hydrogene
Methane
Metabolomics
Stool volume
Stool frequency

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases