Tolerance
Conditions
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.
Interventions
OTHERAgave Inulin
3x3 Latin square with 3 periods
OTHERPlacebo
control- 0 (zero) grams/day inulin
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath gas | 21st day of each treatment period | 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. |
| Gastrointestinal tolerance | Daily and weekly | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Daily during each 21 day treatment period | 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. |
| Weekly Gastrointestinal Tolerance Questions | Weekly during each treatment period | 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). |
| Fecal fermentation end products | Days 16-20 of each treatment period | 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. |
| Daily food intake journals | Daily during each 21-day treatment period | 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 Stool Characteristics | Daily during each 21 day treatment period | 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. |
| Fecal bacteria | Days 16-20 of each treatment period | Aliquots of fecal samples will be used to quantify bacteria present within fecal samples. |
Countries
United States
Outcome results
None listed