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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
Sponsor:
Information provided by (Responsible Party):
Clinical Nutrition Research Center, Illinois Institute of Technology

Brief Summary:

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Active Treatment
Polydextrose 12 g
Dietary Supplement: Polydextrose
Polydextrose 12 g

Placebo Comparator: Control Treatment
No polydextrose
Dietary Supplement: Control Treatment
no polydextrose




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Clinical Nutrition Research Center, Illinois Institute of Technology
Investigators
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Principal Investigator: Britt M Burton-Freeman, Ph.D Illinois Institute of Technology

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Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT02831738    
Other Study ID Numbers: IRB2016-054
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Clinical Nutrition Research Center, Illinois Institute of Technology:
Fiber
Polydextrose
Glycemic Index