This trial is active, not recruiting.

Condition healthy
Treatments polydextrose, control treatment
Sponsor Institute for Food Safety and Health, United States
Start date July 2016
End date October 2018
Trial size 20 participants
Trial identifier NCT02831738, IRB2016-054


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Primary purpose basic science
Masking participant
Polydextrose 12 g
Polydextrose 12 g
(Placebo Comparator)
No polydextrose
control treatment
no polydextrose

Primary Outcomes

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

Secondary Outcomes

Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.
time frame: 3 days

Eligibility Criteria

All participants from 20 years up to 55 years old.

Inclusion Criteria: - *Subject is male or female aged between 20 and 55 years of age - Subject has BMI between 20.0 and 32.0 kg/m2 at the screening visit - Fasting blood sugar less than 126 mg/dL - Subject is willing to maintain a stable body weight and to follow his/her regular diet and physical activity patterns throughout the study period. - Subject is willing to refrain from vigorous physical activity and consumption of alcoholic and/or caffeinated beverages 24 h prior to each test day - Subject does not smoke or has abstained from smoking for at least 2 years - No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease - Not taking any medications or dietary supplements that would interfere with outcomes of the study. - Subject typically consumes a low fiber diet that correlates with the average fiber intake of typical western diet. Exclusion Criteria: - *Subject currently smokes or has smoked within the past 2 years - Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compounds - Men and women known to have/diagnosed with diabetes mellitus - Men and women with a fasting blood glucose concentration ≥126 mg/dL - Average blood pressure > 140 mmHg/90 mmHg during screening visit - Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries - Men and women with cancer other than non-melanoma skin cancer in previous 5 years - Men and women who are taking medication or dietary supplements that may interfere with the outcomes of the study. Subjects may choose to go off dietary supplements (requires 30 days washout)

Additional Information

Official title Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose in Dry Form
Principal investigator Britt M Burton-Freeman, Ph.D
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.