An interventional study of Polydextrose and Control Treatment in Healthy, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Basic science
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.
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.
Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
*Subject is male or female aged between 20 and 55 years of age
Exclusion Criteria:
*Subject currently smokes or has smoked within the past 2 years
Polydextrose 12 g
Dietary Supplement: Polydextrose
No polydextrose
Dietary Supplement: Control Treatment
Polydextrose 12 g
no polydextrose
Changes in plasma glucose concentration over a 3 hour Postprandial Test day after administration of Polydextrose (12g) compared to Placebo (0 g)
plasma glucose concentration over a 3 hour Postprandial Test day
Time frame: 3 hours
Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.
Gastrointestinal tolerance using the questionnaire in 3 days following treatment administration
Time frame: 3 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Clinical Nutrition Research Center, Illinois Institute of Technology