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

NCT03796286 | Completed

• 1 other identifier: MB-1805
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Glucose; Insulin Sensitivity; Dietary Fiber

Keywords

Postprandial glucose; Meal tolerance test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the incremental area under the curve 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 glucose.

Study Arms (3)

Control bar (0 g fiber)

PLACEBO COMPARATOR

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)

Medium-fiber bar

EXPERIMENTAL

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

High-fiber bar

EXPERIMENTAL

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

Interventions

Medium-fiber bar OTHER

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.

Medium-fiber bar

High-fiber bar OTHER

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

Control bar (0 g fiber) OTHER

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Ingredion Incorporated: collaborator

Study Sites (2)

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevin Maki, PhD

  MB Clinical Research and Consulting LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: December 14, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)