Effect of Fiber on Glycemic Index
Fiber2
Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose
1 other identifier
interventional
40
1 country
1
Brief Summary
Primary objective is to investigate the effect of polydextrose on postprandial glucose concentrations in healthy adults when added to a food product. Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Nov 2015
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2018
CompletedJanuary 27, 2021
January 1, 2021
1.3 years
November 20, 2015
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in plasma glucose concentration over a 3 hour Oral Glucose Tolerance Test (OGTT) after administration of polydextrose (8 g, 12g, 16 g) compared to 0 mg placebo
3-hour Acute Postprandial plasma glucose Responses
3 hours
Secondary Outcomes (2)
Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.
3 days
Changes in bowel movement using the questionnaire in 3 days following treatment administrations.
3 days
Study Arms (4)
Active Treatment 1
EXPERIMENTAL8g Polydextrose
Active Treatment 2
EXPERIMENTAL12 g Polydextrose
Active Treatment 3
EXPERIMENTAL16 g Polydextrose
Placebo
PLACEBO COMPARATOR0 g Polydextrose
Interventions
Eligibility Criteria
You may qualify if:
- 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 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.
You may not qualify if:
- 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)
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumption (\> 4 cups/day)
- Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
- Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirements
- Special or atypical diet - eg. vegan, gluten free, excessively high or low energy/fiber
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Center
Chicago, Illinois, 60616, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Britt Britt Burton-Freeman, Ph.D
Illinois Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
November 26, 2015
Study Start
November 1, 2015
Primary Completion
February 22, 2017
Study Completion
December 19, 2018
Last Updated
January 27, 2021
Record last verified: 2021-01