Assessing Fermentability of a Dietary Fiber

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2012-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nutritional Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Placebo Beverage

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

A dietary fiber (FCHO)

15g/BID

Group Type ACTIVE_COMPARATOR

A dietary fiber (FCHO)

Intervention Type DIETARY_SUPPLEMENT

15 g twice per day in beverage

Interventions

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A dietary fiber (FCHO)

15 g twice per day in beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FCHO PCB

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes