Tolerance and Utilization of Agave Inulin in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tolerance and Utilization of Agave Inulin in Healthy Adults

Conditions
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Tolerance

Intervention / Treatment
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* Other: Agave Inulin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |