Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT03046667
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2017-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-05', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metabolic profile in 24h urine collections', 'timeFrame': '0 and 6 weeks', '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)'}, {'measure': 'Metabolic profile in 3d fecal collections', 'timeFrame': '0 and 6 weeks', '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)'}], 'primaryOutcomes': [{'measure': 'Stool volume', 'timeFrame': '0 and 6 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Hydrogen', 'timeFrame': '0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min', 'description': 'Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.'}, {'measure': 'Methane', 'timeFrame': '0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min', 'description': 'Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.'}, {'measure': 'Hydrogen Area Under the Curve', 'timeFrame': '-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min', 'description': 'Area Under the Curve (AUC) for exhaled hydrogen'}, {'measure': 'Methane Area Under the Curve', 'timeFrame': '-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min', 'description': 'Area Under the Curve (AUC) for exhaled methane'}, {'measure': 'Fecal concentrations of SCFA', 'timeFrame': '0 and 6 weeks', 'description': 'Changes in SCFA concentrations determined by a mixed model analysis'}, {'measure': 'Determination and variations in fecal microbiota', 'timeFrame': '0 and 6 weeks', 'description': 'Changes in microbiota determined by a mixed model analysis'}, {'measure': 'Fecal concentrations of calprotectin', 'timeFrame': '0 and 6 weeks', 'description': 'Changes in calprotectin concentrations determined by a mixed model analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beta glucans', 'Barley', 'SCFA', 'Calprotectin', 'Microbiota', 'Hydrogene', 'Methane', 'Metabolomics', 'Stool volume', 'Stool frequency'], 'conditions': ['Irritable Bowel']}, 'descriptionModule': {'briefSummary': "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).\n\nFurther, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 20 - 27 kg/m2\n* Like test and control drink, pasta, meat sauce as these foods are part of the test meal.\n* Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation\n* Willing to handle in 2 x 3-day total feces at the start and end of the study\n\nExclusion Criteria:\n\n* Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD).\n* Systemic infections, psychiatric or metabolic diseases, and any clinical condition\n* Chronic or frequent use of medication (including blood thinners, excluding contraceptives)\n* Frequent loose stools\n* Blood donations during or in the month leading up to the study period\n* Elite athletes (\\> 10 hours of hard exercise / week, self-reported)\n* High intake of alcohol (defined as a weekly intake of \\> 7 units for women and \\> 14 units for men),\n* Have or have had a drug addiction\n* Participation in other scientific studies during the study period\n* Lactating\n* Pregnancy or ongoing planning of pregnancy\n* Vegetarianism or veganism.'}, 'identificationModule': {'nctId': 'NCT03046667', 'acronym': 'NEWDRINK', 'briefTitle': 'Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health', 'orgStudyIdInfo': {'id': 'M230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test drink', 'description': 'Test drink: Barley β-glucan', 'interventionNames': ['Dietary Supplement: Barley β-glucan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control drink', 'description': 'Control drink: barley beverage', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Barley β-glucan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['barley beta-glucan beverages'], '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.', 'armGroupLabels': ['Test drink']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['barley drink'], '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', 'armGroupLabels': ['Control drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Lars Ove Dragsted, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'url': 'https://enpadasi.science.ku.dk/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': '24 months from completion', 'ipdSharing': 'YES', 'description': 'After full anonymization the data may be shared pending acceptance by sponsor approximately 24 months after completion.', 'accessCriteria': 'Full access to published, anonymized data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlsberg Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Lars Ove Dragsted', 'investigatorAffiliation': 'University of Copenhagen'}}}}