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

Insulin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796286
• Other study ID #: MB-1805
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Blood Glucose
• Dietary Fiber
• Insulin Resistance
• Insulin Sensitivity

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.