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| Name | Class |
|---|---|
| Ingredion Incorporated | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Beverage |
|
| A dietary fiber (FCHO) | Active Comparator | 15g/BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A dietary fiber (FCHO) | Dietary Supplement | 15 g twice per day in beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women | 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. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute for Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
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| Placebo | Dietary Supplement | Placebo drink |
|
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| 8 hours |
| The tolerability of treatments over 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. | 7 days |