A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses



Status:Active, not recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:2/20/2019
Start Date:December 14, 2018
End Date:March 6, 2019

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A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.

This randomized, crossover study will include four clinic visits: one screening (day -7) and
three test visits (days 0, 2, 4). The objective of this study is to assess the effects of
dietary fiber-containing bars, at two doses of fiber, compared to a control product, on
postprandial glucose and insulin responses in healthy adult men and women.


Inclusion Criteria:

- Male or female, 18-65 y of age, inclusive.

- 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:

- Individual has a clinically significant gastrointestinal, endocrine (including Type 1
and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic,
neurologic, or biliary disorder.

- 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.
We found this trial at
2
sites
Chicago, Illinois 60640
Principal Investigator: Rupal Trivedi, MD
Phone: 773-275-3500
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Chicago, IL
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Boca Raton, Florida 33434
Principal Investigator: Mary Buggia, MD
Phone: 561-757-5766
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Boca Raton, FL
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