Clinical trial NCT01925560: Tolerance and Utilization of Agave Inulin in Healthy Adults
Official title: Tolerance and Utilization of Agave Inulin in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* have body mass index (BMI) between 18.5 and 29.5 kg/m2
* free of metabolic and gastrointestinal diseases

Exclusion Criteria:

* 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

Primary outcomes:
measure: Breath gas
timeFrame: 21st day of each treatment period
measure: Gastrointestinal tolerance
timeFrame: Daily and weekly
Secondary outcomes:
measure: Fecal fermentation end products
timeFrame: Days 16-20 of each treatment period
measure: Fecal bacteria
timeFrame: Days 16-20 of each treatment period
measure: Gastrointestinal Tolerance
timeFrame: Daily during each 21 day treatment period
measure: Weekly Gastrointestinal Tolerance Questions
timeFrame: Weekly during each treatment period
measure: Daily Stool Characteristics
timeFrame: Daily during each 21 day treatment period
measure: Daily food intake journals
timeFrame: Daily during each 21-day treatment period
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: UIUC
name: Kelly Swanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.