Effect of Fiber on Glycemic Index

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02615327

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

40

Starts

2015-11-01

Expected to finish

2018-12-19

Last updated by the study team

2021-01-27

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
• Men and women who do excessive exercise regularly or athlete

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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