Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response

Hyperglycemia, Diabetes, and Obesity Clinical Trial

Official title:

Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02187913
• Other study ID #: 1406014929
• Status: Unknown status
• Phase: N/A
• First received: July 9, 2014
• Last updated: July 10, 2014
• Start date: July 2014

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. primary completion date: December 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 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

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