Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective is to investigate the effect of polydextrose on postprandial glucose concentrations in healthy adults when added to a food product.
Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.
This study is a randomized, 4-arm, single-blinded, controlled, cross-over trial design focused on determining the health benefits associated with Polydextrose intake.
A planned sample size of 40 will be enrolled into the study. This study will require one initial screening visit and 4 weekly study visits. This study will take approximately 4 weeks per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 4 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration. A dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a placebo or treatment beverage based on randomized treatment sequences for 4 study visits. The sequences of receiving the beverage treatments at each visit will be randomly assigned to one of sequences.
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 3 hour (h) for assessment of change in plasma glucose and insulin concentrations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment 1 | Experimental | 8g Polydextrose |
|
| Active Treatment 2 | Experimental | 12 g Polydextrose |
|
| Active Treatment 3 | Experimental | 16 g Polydextrose |
|
| Placebo | Placebo Comparator | 0 g Polydextrose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8 g Polydextrose | Dietary Supplement | 8g of Polydextrose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma glucose concentration over a 3 hour Oral Glucose Tolerance Test (OGTT) after administration of polydextrose (8 g, 12g, 16 g) compared to 0 mg placebo | 3-hour Acute Postprandial plasma glucose Responses | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations. | 3 days after administration of each treatment | 3 days |
| Changes in bowel movement using the questionnaire in 3 days following treatment administrations. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Britt Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
Not provided
| ID | Term |
|---|---|
| C033375 | polydextrose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 g Polydextrose |
| Dietary Supplement |
12 g of Polydextrose |
|
| 16 g Polydextrose | Dietary Supplement | 16 g of Polydextrose |
|
| Placebo | Dietary Supplement | 0 g of Polydextrose |
|
3 days after administration of each treatment |
| 3 days |