Assessing Fermentability of a Dietary Fiber



Status:Active, not recruiting
Conditions:Food Studies
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - 65
Updated:7/14/2018
Start Date:December 1, 2011
End Date:September 1, 2019

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Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women

The objective of this study is to provide evidence for its fermentability of a dietary fiber
and to collect information regarding potential health opportunities for glucose control as
well as tolerability when being consumed over 7 days.

This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour
postprandial crossover study, utilizing a multiple sampling paradigm to evaluate
fermentability and potential health opportunities for glucose control of a dietary fiber
(FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments
following consumption of the FCHO drink or a placebo drink and will follow with a 7 day
feeding period to assess tolerability.

Inclusion Criteria:

- 18 years of age or older

- BMI between 18.5 and 29.9 kg/m2, inclusive

- No clinical evidence of cardiovascular, metabolic, respiratory, renal,
gastrointestinal, or hepatic disease

- No diabetes

- No Gastrointestinal issues

Exclusion Criteria:

- Pregnant and/or lactating or planning for pregnancy

- Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125
mg/dL.

- Vegetarian

- Taking over the counter fiber supplements or other supplements that may interfere with
the study procedures or endpoints

- Taking actively probiotics or purposely taking/ subscribing to a diet high in
prebiotics.

- Taking prescription medications that may interfere with study procedures or endpoints
(eg., antibiotics)

- Subjects with unusual dietary habits (e.g. pica)

- Actively losing weight or trying to lose weight (unstable body weight fluctuations of
> 5 kg in a 60 day period)

- Excessive exercisers or trained athletes

- Addicted to drugs and/or alcohol

- Medically documented psychiatric or neurological disturbances

- Smokers (past smokers may be allowed if cessation is > 2 years)
We found this trial at
1
site
Chicago, Illinois 60616
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from
Chicago, IL
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