Overview

This trial is active, not recruiting.

Condition nutritional intervention
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 2017
Trial size 29 participants
Trial identifier NCT01497249, FCHO 2011-086

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo Beverage
placebo PCB
Placebo drink
(Active Comparator)
15g/BID
a dietary fiber (fcho) FCHO
15 g twice per day in beverage

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
time frame: 8 hours

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female 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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.