Nutritional Intervention
Conditions
Keywords
Dietary Fiber, Blood glucose control, Fermentability, Tolerability
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.
Interventions
DIETARY_SUPPLEMENTA dietary fiber (FCHO)
15 g twice per day in beverage
DIETARY_SUPPLEMENTPlacebo
Placebo drink
Sponsors
Ingredion Incorporated
Clinical Nutrition Research Center, Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women | 8 hours | FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink | 8 hours | FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Blood glucose will be measured before (fasting/baseline) and after breakfast test meal intake for 4hrs: 0, 30 min, 60 min, 120 min, and 240 min and then again after the light lunch meal at 30, 60, 90, 120 post lunch. |
| The tolerability of treatments over 7 days | 7 days | After the in-lab study day (visit 1 and visit 2), subjects will go home with the test beverage packs to be consumed daily for 7 days. Subjects will maintain diaries to ensure daily consumption and on day 7 will be asked to complete a brief questionnaire related to gastrointestinal experiences during the week. Identical procedures will take place after both study days, except the assigned treatment will differ. |
Countries
United States
Outcome results
None listed