Back to resultsA Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
Primary Purpose
Blood Glucose, Insulin Sensitivity, Dietary Fiber
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium-fiber bar
High-fiber bar
Control bar (0 g fiber)
Sponsored by
About this trial
This is an interventional other trial for Blood Glucose focused on measuring Postprandial glucose, Meal tolerance test
Eligibility Criteria
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.
Sites / Locations
- MB Clinical Research
- Great Lakes Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control bar (0 g fiber)
Medium-fiber bar
High-fiber bar
Arm Description
Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.
Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.
Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03796286
First Posted
January 4, 2019
Last Updated
July 23, 2019
Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Ingredion Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03796286
Brief Title
A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
Official Title
A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Ingredion Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Glucose, Insulin Sensitivity, Dietary Fiber
Keywords
Postprandial glucose, Meal tolerance test
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code.
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control bar (0 g fiber)
Arm Type
Placebo Comparator
Arm Description
Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.
Arm Title
Medium-fiber bar
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.
Arm Title
High-fiber bar
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.
Intervention Type
Other
Intervention Name(s)
Medium-fiber bar
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-fiber bar
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control bar (0 g fiber)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the incremental area under the curve for capillary glucose.
Description
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.
Time Frame
Up to 120 minutes - measured at each treatment visit
Secondary Outcome Measure Information:
Title
Change in the incremental area under the curve for venous glucose.
Description
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.
Time Frame
Up to 120 minutes - measured at each treatment visit
Title
Change in the incremental area under the curve for venous insulin.
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Maki, PhD
Organizational Affiliation
MB Clinical Research and Consulting LLC
Official's Role
Study Director
Facility Information:
Facility Name
MB Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
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