A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
NCT ID: NCT03796286
Last Updated: 2019-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2018-12-14
2019-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Control bar (0 g fiber)
Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.
Control bar (0 g fiber)
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Medium-fiber bar
Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.
Medium-fiber bar
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
High-fiber bar
Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.
High-fiber bar
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Interventions
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Medium-fiber bar
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
High-fiber bar
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Control bar (0 g fiber)
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Eligibility Criteria
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Inclusion Criteria
* Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.
* Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
* Subject is willing to consume the study products as described in the protocol.
* Subject is willing to maintain usual diet and activity patterns throughout the study.
* Subject has no plans to change smoking or other nicotine use during the study period.
* Subject is willing and able to attend all clinic visits.
* Subject has a vein access scale score of 7-10.
* Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Exclusion Criteria
* Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at screening. One re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at screening (visit 1).
* Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
* Individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Individual has extreme dietary habits (e.g., Atkins, vegan).
* Individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months.
* Individual has a known allergy, sensitivity, or intolerance to any ingredients in the study products.
* Individual is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Individual has been exposed to any non-registered drug product within 30 days of screening.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
18 Years
65 Years
ALL
Yes
Sponsors
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Ingredion Incorporated
INDUSTRY
Midwest Center for Metabolic and Cardiovascular Research
OTHER
Responsible Party
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Principal Investigators
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Kevin Maki, PhD
Role: STUDY_DIRECTOR
MB Clinical Research and Consulting LLC
Locations
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MB Clinical Research
Boca Raton, Florida, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Countries
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Other Identifiers
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MB-1805
Identifier Type: -
Identifier Source: org_study_id
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