Assessing Fermentability of a Dietary Fiber (FCHO)

Illinois Institute of Technology

Status: Completed

Conditions: Nutritional Intervention

Treatments: Dietary Supplement: A dietary fiber (FCHO); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497249

FCHO 2011-086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Beverage

Treatment:

Dietary Supplement: Placebo

A dietary fiber (FCHO)

Active Comparator group

Description:

15g/BID

Treatment:

Dietary Supplement: A dietary fiber (FCHO)