Back to resultsEffect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health (NEWDRINK)
Primary Purpose
Irritable Bowel
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Barley β-glucan
Control
Sponsored by
About this trial
This is an interventional prevention trial for Irritable Bowel focused on measuring Beta glucans, Barley, SCFA, Calprotectin, Microbiota, Hydrogene, Methane, Metabolomics, Stool volume, Stool frequency
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.
Sites / Locations
- Department of Nutrition, Exercise and Sports, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test drink
Control drink
Arm Description
Test drink: Barley β-glucan
Control drink: barley beverage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hydrogen
Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
Methane
Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
Hydrogen Area Under the Curve
Area Under the Curve (AUC) for exhaled hydrogen
Methane Area Under the Curve
Area Under the Curve (AUC) for exhaled methane
Fecal concentrations of SCFA
Changes in SCFA concentrations determined by a mixed model analysis
Determination and variations in fecal microbiota
Changes in microbiota determined by a mixed model analysis
Fecal concentrations of calprotectin
Changes in calprotectin concentrations determined by a mixed model analysis
Full Information
NCT ID
NCT03046667
First Posted
February 2, 2017
Last Updated
December 11, 2017
Sponsor
University of Copenhagen
Collaborators
Carlsberg Group
1. Study Identification
Unique Protocol Identification Number
NCT03046667
Brief Title
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Acronym
NEWDRINK
Official Title
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Carlsberg Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel
Keywords
Beta glucans, Barley, SCFA, Calprotectin, Microbiota, Hydrogene, Methane, Metabolomics, Stool volume, Stool frequency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test drink
Arm Type
Experimental
Arm Description
Test drink: Barley β-glucan
Arm Title
Control drink
Arm Type
Placebo Comparator
Arm Description
Control drink: barley beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Barley β-glucan
Other Intervention Name(s)
barley beta-glucan beverages
Intervention Description
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
Intervention Name(s)
Control
Other Intervention Name(s)
barley drink
Intervention Description
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
Primary Outcome Measure Information:
Title
Stool volume
Description
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.
Time Frame
0 and 6 weeks
Secondary Outcome Measure Information:
Title
Hydrogen
Description
Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Title
Methane
Description
Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Title
Hydrogen Area Under the Curve
Description
Area Under the Curve (AUC) for exhaled hydrogen
Time Frame
-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Title
Methane Area Under the Curve
Description
Area Under the Curve (AUC) for exhaled methane
Time Frame
-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Title
Fecal concentrations of SCFA
Description
Changes in SCFA concentrations determined by a mixed model analysis
Time Frame
0 and 6 weeks
Title
Determination and variations in fecal microbiota
Description
Changes in microbiota determined by a mixed model analysis
Time Frame
0 and 6 weeks
Title
Fecal concentrations of calprotectin
Description
Changes in calprotectin concentrations determined by a mixed model analysis
Time Frame
0 and 6 weeks
Other Pre-specified Outcome Measures:
Title
Metabolic profile in 24h urine collections
Description
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)
Time Frame
0 and 6 weeks
Title
Metabolic profile in 3d fecal collections
Description
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)
Time Frame
0 and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Ove Dragsted, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports, University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After full anonymization the data may be shared pending acceptance by sponsor approximately 24 months after completion.
IPD Sharing Time Frame
24 months from completion
IPD Sharing Access Criteria
Full access to published, anonymized data
IPD Sharing URL
https://enpadasi.science.ku.dk/
Learn more about this trial
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
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