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Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses

Primary Purpose

Hyperglycemia, Diabetes, and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistant Starch
Control
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperglycemia, Diabetes, and Obesity

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh >110 pounds, with a BMI between 20.0 and 29.9.

Exclusion Criteria:

  • Weight change > 3kg in the past 3 months
  • Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
  • Intestinal disorders including lipid mal-absorption or lactose intolerance
  • Abnormal liver or kidney function tests; fasting blood glucose >100mg/dL
  • Smoking
  • Drinking more than 2 alcoholic drinks per day
  • Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
  • Subjects must not be pregnant or lactating.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Resistant starch

Control

Arm Description

The test beverage consumed has the resistant starch.

The control beverage uses maltodextrin rather than the resistant starch.

Outcomes

Primary Outcome Measures

resistant starch effects
effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2014
Last Updated
June 11, 2014
Sponsor
Purdue University
Collaborators
Ingredion Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02161250
Brief Title
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Official Title
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Ingredion Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).
Detailed Description
About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations. Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations. Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Diabetes, and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistant starch
Arm Type
Experimental
Arm Description
The test beverage consumed has the resistant starch.
Arm Title
Control
Arm Type
Experimental
Arm Description
The control beverage uses maltodextrin rather than the resistant starch.
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant Starch
Intervention Description
Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
Primary Outcome Measure Information:
Title
resistant starch effects
Description
effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh >110 pounds, with a BMI between 20.0 and 29.9. Exclusion Criteria: Weight change > 3kg in the past 3 months Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day Intestinal disorders including lipid mal-absorption or lactose intolerance Abnormal liver or kidney function tests; fasting blood glucose >100mg/dL Smoking Drinking more than 2 alcoholic drinks per day Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration. Subjects must not be pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Campbell, Phd
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States

12. IPD Sharing Statement

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Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses

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