Tolerance and Utilization of Agave Inulin in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-05-31

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.

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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.

Conditions

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Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Agave Inulin

Intervention Type OTHER

3x3 Latin square with 3 periods

Placebo

Intervention Type OTHER

control- 0 (zero) grams/day inulin

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

Group Type EXPERIMENTAL

Agave Inulin

Intervention Type OTHER

3x3 Latin square with 3 periods

Placebo

Intervention Type OTHER

control- 0 (zero) grams/day inulin

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

Group Type EXPERIMENTAL

Agave Inulin

Intervention Type OTHER

3x3 Latin square with 3 periods

Placebo

Intervention Type OTHER

control- 0 (zero) grams/day inulin

Interventions

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Agave Inulin

3x3 Latin square with 3 periods

Intervention Type OTHER

Placebo

control- 0 (zero) grams/day inulin

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes