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

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose; Insulin Sensitivity; Dietary Fiber
• Intervention / Treatment: Other: Control bar (0 g fiber); Other: Medium-fiber bar; Other: High-fiber bar

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33487
      • MB Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: Ingredion Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Postprandial glucose; Meal tolerance test
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: MB-1805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No