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Tolerance and Utilization of Agave Inulin in Healthy Adults

U

University of Illinois at Urbana-Champaign

Status

Completed

Conditions

Tolerance

Treatments

Other: Placebo
Other: Agave Inulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01925560
13359 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups

Group A- agave inulin or placebo
Experimental group
Description:
Participant in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo.
Treatment:
Other: Placebo
Other: Agave Inulin
Group B- agave inulin or placebo
Experimental group
Description:
Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo
Treatment:
Other: Placebo
Other: Agave Inulin
Group C-agave inulin or placebo
Experimental group
Description:
Participants in this group will receive Agave Inulin dose of 5 or 7.5 grams per day or placebo
Treatment:
Other: Placebo
Other: Agave Inulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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