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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03796286
Other study ID # MB-1805
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 14, 2018
Est. completion date February 27, 2019

Study information

Verified date July 2019
Source Midwest Center for Metabolic and Cardiovascular Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 27, 2019
Est. primary completion date February 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Other:
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.

Locations

Country Name City State
United States MB Clinical Research Boca Raton Florida
United States Great Lakes Clinical Trials Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Midwest Center for Metabolic and Cardiovascular Research Ingredion Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the incremental area under the curve for capillary glucose. Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose. Up to 120 minutes - measured at each treatment visit
Secondary Change in the incremental area under the curve for venous glucose. Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose. Up to 120 minutes - measured at each treatment visit
Secondary Change in the incremental area under the curve for venous insulin. Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin. Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
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