Assessing Fermentability of a Dietary Fiber
This trial is active, not recruiting.
|Treatments||a dietary fiber (fcho), placebo|
|Sponsor||Institute for Food Safety and Health, United States|
|Collaborator||National Starch LLC|
|Start date||December 2011|
|End date||September 2018|
|Trial size||29 participants|
|Trial identifier||NCT01497249, FCHO 2011-086|
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.
|Intervention model||crossover assignment|
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
time frame: 8 hours
The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink
time frame: 8 hours
The tolerability of treatments over 7 days
time frame: 7 days
All participants from 18 years up to 65 years old.
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)
|Official title||Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women|
|Principal investigator||Britt Burton-Freeman, Ph.D|
|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.|
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