Tolerance and Utilization of Agave Inulin in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Breath gas
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Breath gas
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Daily food intake journals(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)