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

Hyperglycemia, Diabetes, and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161250
• Other study ID #: 1312014354
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: June 11, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia, Diabetes, and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Ingredion Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resistant starch effects	effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.	2 weeks