- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161250
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
June 11, 2014 updated by: Wayne Campbell, Purdue University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
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West Lafayette, Indiana, United States, 47905
- Purdue University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistant starch
The test beverage consumed has the resistant starch.
|
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.
|
Experimental: Control
The control beverage uses maltodextrin rather than the resistant starch.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
resistant starch effects
Time Frame: 2 weeks
|
effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.
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2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wayne Campbell, PhD, Purdue University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 9, 2014
First Submitted That Met QC Criteria
June 10, 2014
First Posted (Estimate)
June 11, 2014
Study Record Updates
Last Update Posted (Estimate)
June 12, 2014
Last Update Submitted That Met QC Criteria
June 11, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1312014354
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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