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

• ClinicalTrials.gov Identifier: NCT03796286
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: July 24, 2019
• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborator: Ingredion Incorporated
• Information provided by (Responsible Party): Midwest Center for Metabolic and Cardiovascular Research

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.

Condition or disease	Intervention/treatment	Phase
Blood Glucose; Insulin Sensitivity; Dietary Fiber	Other: Medium-fiber bar; Other: High-fiber bar; Other: Control bar (0 g fiber)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
• Primary Purpose: Other
• Official Title: A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.
• Actual Study Start Date: December 14, 2018
• Actual Primary Completion Date: February 27, 2019
• Actual Study Completion Date: February 27, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Other: 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.
Experimental: Medium-fiber bar; Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.	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.
Experimental: High-fiber bar; Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in the incremental area under the curve for capillary glucose. [ Time Frame: Up to 120 minutes - measured at each treatment visit ]
   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 :

1. Change in the incremental area under the curve for venous glucose. [ Time Frame: Up to 120 minutes - measured at each treatment visit ]
   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.
2. Change in the incremental area under the curve 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

MB Clinical Research

Boca Raton, Florida, United States, 33487

United States, Illinois

Great Lakes Clinical Trials

Chicago, Illinois, United States, 60640

Sponsors and Collaborators

Midwest Center for Metabolic and Cardiovascular Research

Ingredion Incorporated

Investigators

• Study Director: Kevin Maki, PhD; MB Clinical Research and Consulting LLC

More Information

• Responsible Party: Midwest Center for Metabolic and Cardiovascular Research
• ClinicalTrials.gov Identifier: NCT03796286
• Other Study ID Numbers: MB-1805
• First Posted: January 8, 2019
• Last Update Posted: July 24, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Midwest Center for Metabolic and Cardiovascular Research:

Postprandial glucose; Meal tolerance test

Additional relevant MeSH terms:

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases