Fiber Effects on Glycemic Index (PDX2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02831738|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : April 22, 2019
Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial visit after administration of polydextrose (12g) compared to 0 mg placebo.
Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3 days following treatment administration.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Polydextrose Dietary Supplement: Control Treatment||Not Applicable|
This study is a randomized, 2-arm, single-blinded, controlled, cross-over trial design focused on determining the health benefits associated with Polydextrose intake.
A planned sample size of 20 will be enrolled into the study. This study will require one initial screening visit and 2 weekly study visits. This study will take approximately 2-3 weeks per subject to complete both 3-hr study visits on two different occasions.
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 2 study visits. 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 test food based on randomized treatment sequences for 2 study visits on two different occasions. The sequences of receiving the test food 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 concentrations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose in Dry Form|
|Actual Study Start Date :||July 2, 2016|
|Estimated Primary Completion Date :||October 2, 2021|
|Estimated Study Completion Date :||October 2, 2021|
Experimental: Active Treatment
Polydextrose 12 g
Dietary Supplement: Polydextrose
Polydextrose 12 g
Placebo Comparator: Control Treatment
Dietary Supplement: Control Treatment
- Changes in plasma glucose concentration over a 3 hour Postprandial Test day after administration of Polydextrose (12g) compared to Placebo (0 g) [ Time Frame: 3 hours ]plasma glucose concentration over a 3 hour Postprandial Test day
- Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations. [ Time Frame: 3 days ]Gastrointestinal tolerance using the questionnaire in 3 days following treatment administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831738
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Britt M Burton-Freeman, Ph.D||Illinois Institute of Technology|