HealthyPDX2NCT02831738
Fiber Effects on Glycemic Index
A study testing Polydextrose in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2016to 25 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- *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
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- 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.
Who cannot join
- *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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose in Dry Form
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Polydextrose, Control Treatment
- Keywords
- Fiber, Polydextrose, Glycemic Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydextroseDietary supplement
Polydextrose 12 g
Control TreatmentDietary supplement
no polydextrose
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Polydextrose 12 g Receives: Dietary Supplement: Polydextrose |
| Control Treatment | Placebo comparator | No polydextrose Receives: Dietary Supplement: Control Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (1)
Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.
Gastrointestinal tolerance using the questionnaire in 3 days following treatment administration
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start2 Jul 2016
- Primary completion30 Aug 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt M Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831738
- Sponsor's protocol ID
- IRB2016-054
- Acronym
- PDX2
- Status last verified
- Jan 2021
- First submitted
- 11 Jul 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose in Dry Form
- ClinicalTrials.gov ID
- NCT02831738
- Acronym / sponsor ID
- PDX2 / IRB2016-054
- Conditions
- Healthy
- Keywords
- Fiber, Polydextrose, Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Dietary Supplement: PolydextrosePolydextrose 12 g |
| Control Treatment | Placebo comparator | Dietary Supplement: Control TreatmentNo polydextrose |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- *Subject is male or female aged between 20 and 55 years of age
Key exclusion criteria (8 listed)
- *Subject currently smokes or has smoked within the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydextrosePolydextrose 12 g | Dietary supplement | Active Treatment |
| Control Treatmentno polydextrose | Dietary supplement | Control Treatment |
Primary outcome
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
1 secondary outcome
Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt M Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.