Tolerance and Utilization of Agave Inulin in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Other: Agave Inulin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A- agave inulin or placebo; Participant in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo.	Other: Agave Inulin; 3x3 Latin square with 3 periods; Other: Placebo; control- 0 (zero) grams/day inulin
EXPERIMENTAL: Group B- agave inulin or placebo; Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo	Other: Agave Inulin; 3x3 Latin square with 3 periods; Other: Placebo; control- 0 (zero) grams/day inulin
EXPERIMENTAL: Group C-agave inulin or placebo; Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo	Other: Agave Inulin; 3x3 Latin square with 3 periods; Other: Placebo; control- 0 (zero) grams/day inulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal fermentation end products	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.	Days 16-20 of each treatment period
Fecal bacteria	Aliquots of fecal samples will be used to quantify bacteria present within fecal samples.	Days 16-20 of each treatment period
Gastrointestinal Tolerance	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.	Daily during each 21 day treatment period
Weekly Gastrointestinal Tolerance Questions	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).	Weekly during each treatment period
Daily Stool Characteristics	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. Stool 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.	Daily during each 21 day treatment period
Daily food intake journals	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.	Daily during each 21-day treatment period

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (ESTIMATE): August 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13359 (OTHER_GRANT: Ingredion Inc.)