Tolerance and Utilization of Agave Inulin in Healthy Adults
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 14, 2014
May 1, 2014
4 months
April 17, 2013
May 13, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Breath gas
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.
21st day of each treatment period
Gastrointestinal tolerance
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.
Daily and weekly
Secondary Outcomes (6)
Fecal fermentation end products
Days 16-20 of each treatment period
Fecal bacteria
Days 16-20 of each treatment period
Gastrointestinal Tolerance
Daily during each 21 day treatment period
Weekly Gastrointestinal Tolerance Questions
Weekly during each treatment period
Daily Stool Characteristics
Daily during each 21 day treatment period
- +1 more secondary outcomes
Study Arms (3)
Group A- agave inulin or placebo
EXPERIMENTALParticipant in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo.
Group B- agave inulin or placebo
EXPERIMENTALParticipants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo
Group C-agave inulin or placebo
EXPERIMENTALParticipants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo
Interventions
3x3 Latin square with 3 periods
control- 0 (zero) grams/day inulin
Eligibility Criteria
You may qualify if:
- have body mass index (BMI) between 18.5 and 29.5 kg/m2
- free of metabolic and gastrointestinal diseases
You may not qualify if:
- BMI less than 18.5 or greater than 29.5 kg/m2
- presence of metabolic and gastrointestinal diseases
- pregnant or lactating
- taking medications that impact bowel function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois
Urbana, Illinois, 61801, United States
Related Publications (2)
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: 28971851DERIVEDHolscher 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.
PMID: 26203099DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Swanson, PhD
UIUC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
August 19, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2014
Last Updated
May 14, 2014
Record last verified: 2014-05