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

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ClinicalTrials.gov Identifier: NCT02161250
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : June 12, 2014
Sponsor:
Collaborator:
Ingredion Incorporated
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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).

Condition or disease Intervention/treatment Phase
Hyperglycemia, Diabetes, and Obesity Dietary Supplement: Resistant Starch Dietary Supplement: Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Study Start Date : April 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Resistant starch
The test beverage consumed has the resistant starch.
Dietary Supplement: 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.
Dietary Supplement: Control
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 Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161250


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47905
Sponsors and Collaborators
Purdue University
Ingredion Incorporated
Investigators
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Principal Investigator: Wayne Campbell, Phd Purdue University
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Responsible Party: Wayne Campbell, Professor, Purdue University
ClinicalTrials.gov Identifier: NCT02161250    
Other Study ID Numbers: 1312014354
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases