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A Randomized, Controlled, Crossover Study to Assess the Glucose and Insulin Excursions of a Test Fiber

NCT03239288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-08-04

No results posted yet for this study

Summary

The objective of this trial is to evaluate the postprandial glucose and insulin responses to replacing digestible carbohydrates with resistant starch type 4 (RS4) in a baked product in healthy men and women. A randomized, double-blinded cross-over study will be conducted comparing two foods (a reference food and a test food). The primary outcome variable will be the incremental area under the curve (iAUC) for capillary glucose from pre-product consumption (average of t = -15 and -5 min) to 120 min (iAUC0-120 min). This study will provide substantiation for a beneficial reduction in glycemic response followed by the consumption of the active product containing an efficacious dose of resistant starch type 4 (RS4).

Conditions

  • Healthy

Interventions

OTHER

Control digestible carbohydrate

Single serving of control product

OTHER

Test resistant starch type 4

Single serving of test product

Sponsors & Collaborators

  • Biofortis Clinical Research, Inc.

    collaborator INDUSTRY

  • Cargill

    lead INDUSTRY

Principal Investigators

  • Kathleen M Kelley, MD · Biofortis Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2017-07-28
Completion
2017-07-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239288 on ClinicalTrials.gov