Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
Primary Purpose
Hyperglycemia, Diabetes, and Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistant starch
Sponsored by
About this trial
This is an interventional basic science trial for Hyperglycemia, Diabetes, and Obesity
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.
Sites / Locations
- Purdue UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Resistant starch
Control
Arm Description
The test snack bar consumed has the resistant starch
The control bar 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
1. Study Identification
Unique Protocol Identification Number
NCT02187913
Brief Title
Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
Official Title
Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 baked snack bar with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a baked snack bar 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 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistant starch
Arm Type
Experimental
Arm Description
The test snack bar consumed has the resistant starch
Arm Title
Control
Arm Type
Experimental
Arm Description
The control bar 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 snack bar containing resistant starch. The test snack bar 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 snack bar will be consumed four hours later.
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.
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan K Green
Phone
765-494-6342
Email
jkgreen@purdue.edu
12. IPD Sharing Statement
Learn more about this trial
Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
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