Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT01925560
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Utilization of Agave Inulin in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath gas', 'timeFrame': '21st day of each treatment period', 'description': 'On the 21st day of each treatment period, participants will come into the laboratory after an overnight (12 hour) fast and begin breath gas testing. The baseline breath gas sample will occur upon arrive. Breath gas collection will utilize the Quintron EasySampler and tubes. Participants will blow into the EasySampler for 1-2 seconds while inserting a tube into a needle holder that allows the collection of the breath gas. After the baseline sample, the participants will consume their respective treatments. Participants then collect subsequent breath gas samples outside of the laboratory every hour for the next 8 hours. All breath gas samples will then be analyzed for CO2, methane, and H2 gases.'}, {'measure': 'Gastrointestinal tolerance', 'timeFrame': 'Daily and weekly', 'description': 'Participants will complete daily and weekly questionnaires to assess tolerance of up to 7.5 g/d agave inulin. Adults completed a weekly survey while meeting with study personnel. They were asked (Yes or No) if they experienced any of the following gastrointestinal symptoms during the past 7 days: nausea, bloating, gastrointestinal rumblings, gas/flatulence, abdominal pain, diarrhea (watery stools). If yes, they rated the intensity of the symptom as no more than usual (0), somewhat more than usual (1), or much more than usual (2). Participants are provided a journal to complete on their own each day, a questionnaire about their stool characteristics. Participants were asked to score the ease of stool passage using the following scale: 1=very easy, 2=easy, 3=neither easy nor difficult, 4=difficult, 5=very difficult.'}], 'secondaryOutcomes': [{'measure': 'Fecal fermentation end products', 'timeFrame': 'Days 16-20 of each treatment period', 'description': 'Fecal samples will be collected on days 16-20 of each treatment period. Participants were provided fecal collection materials (fecal hats, coolers, ice packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site. Fecal samples will then be processed by a team. Fecal specimens will be aliquoted into containers for fermentation end product analysis (short-chain fatty acids, phenols, indoles, ammonia) and dry matter.'}, {'measure': 'Fecal bacteria', 'timeFrame': 'Days 16-20 of each treatment period', 'description': 'Aliquots of fecal samples will be used to quantify bacteria present within fecal samples.'}, {'measure': 'Gastrointestinal Tolerance', 'timeFrame': 'Daily during each 21 day treatment period', 'description': 'Subjective daily gastrointestinal intolerance symptoms for adult human subjects consuming 0, 5.0, or 7.5 grams of agave inulin in a crossover design will be assessed. Gastrointestinal tolerance was scored using the following scale: 1=absent, 2=mild, 3=moderate, 4=severe. All study participants will have booklets with daily tolerance questionnaires in them. The participants will complete the questionnaires on their own each day.'}, {'measure': 'Weekly Gastrointestinal Tolerance Questions', 'timeFrame': 'Weekly during each treatment period', 'description': 'Adults completed a weekly survey while meeting with study personnel. They were asked (Yes or No) if they experienced any of the following gastrointestinal symptoms during the past 7 days: nausea, bloating, gastrointestinal rumblings, gas/flatulence, abdominal pain, diarrhea (watery stools). If yes, they rated the intensity of the symptom as no more than usual (0), somewhat more than usual (1), or much more than usual (2).'}, {'measure': 'Daily Stool Characteristics', 'timeFrame': 'Daily during each 21 day treatment period', 'description': 'Participants are provided a journal to complete on their own each day, a questionnaire about their stool characteristics. Participants were asked to score the ease of stool passage using the following scale: 1=very easy, 2=easy, 3=neither easy nor difficult, 4=difficult, 5=very difficult.\n\nStool consistency was scored using the Bristol stool scale: 1=separate hard lumps, like nuts; 2=sausage-shaped but lumpy; 3=like a sausage but with cracks on surface; 4=Like a sausage or snake, smooth and soft; 5=soft blobs with clear-cut edges; 6=fluffy pieces with ragged edges, mushy; 7=watery, no solid pieces, entirely liquid.'}, {'measure': 'Daily food intake journals', 'timeFrame': 'Daily during each 21-day treatment period', 'description': 'Participants were provided a journal to record their daily food and beverage intake. Each week the participants met with a study personnel for 30 minutes to review the journal and turn it in.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tolerance']}, 'referencesModule': {'references': [{'pmid': '28971851', 'type': 'DERIVED', 'citation': 'Kaczmarek JL, Musaad SM, Holscher HD. Time of day and eating behaviors are associated with the composition and function of the human gastrointestinal microbiota. Am J Clin Nutr. 2017 Nov;106(5):1220-1231. doi: 10.3945/ajcn.117.156380. Epub 2017 Sep 27.'}, {'pmid': '26203099', 'type': 'DERIVED', 'citation': 'Holscher HD, Bauer LL, Gourineni V, Pelkman CL, Fahey GC Jr, Swanson KS. Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2015 Sep;145(9):2025-32. doi: 10.3945/jn.115.217331. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the tolerance and utilization of agave inulin. This will be accomplished through analyses of breath and fecal samples to quantify fermentation end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial populations will also be measured in fecal samples.', 'detailedDescription': 'The objective of this study is to assess the tolerance and utilization of agave inulin. This will be accomplished through analyses of breath and fecal samples to quantify fermentation end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial populations will also be measured in fecal samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have body mass index (BMI) between 18.5 and 29.5 kg/m2\n* free of metabolic and gastrointestinal diseases\n\nExclusion Criteria:\n\n* BMI less than 18.5 or greater than 29.5 kg/m2\n* presence of metabolic and gastrointestinal diseases\n* pregnant or lactating\n* taking medications that impact bowel function'}, 'identificationModule': {'nctId': 'NCT01925560', 'briefTitle': 'Tolerance and Utilization of Agave Inulin in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Tolerance and Utilization of Agave Inulin in Healthy Adults', 'orgStudyIdInfo': {'id': '13359'}, 'secondaryIdInfos': [{'id': '13359', 'type': 'OTHER_GRANT', 'domain': 'Ingredion Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A- agave inulin or placebo', 'description': 'Participant in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo.', 'interventionNames': ['Other: Agave Inulin', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B- agave inulin or placebo', 'description': 'Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo', 'interventionNames': ['Other: Agave Inulin', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C-agave inulin or placebo', 'description': 'Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo', 'interventionNames': ['Other: Agave Inulin', 'Other: Placebo']}], 'interventions': [{'name': 'Agave Inulin', 'type': 'OTHER', 'description': '3x3 Latin square with 3 periods', 'armGroupLabels': ['Group A- agave inulin or placebo', 'Group B- agave inulin or placebo', 'Group C-agave inulin or placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'control- 0 (zero) grams/day inulin', 'armGroupLabels': ['Group A- agave inulin or placebo', 'Group B- agave inulin or placebo', 'Group C-agave inulin or placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Kelly Swanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UIUC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}