Clinical trial NCT01497249: Assessing Fermentability of a Dietary Fiber
Official title: Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Intervention
Keywords: Dietary Fiber
Blood glucose control
Fermentability
Tolerability
Lead sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sponsor class: INDUSTRY
Collaborators: name: Ingredion Incorporated
First posted: 2011-12-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
timeFrame: 8 hours
Secondary outcomes:
measure: The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink
timeFrame: 8 hours
measure: The tolerability of treatments over 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Nutrition Research Center
state: Illinois
Study officials:
affiliation: Illinois Institute for Technology
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: