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

• 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).

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia, Diabetes, and Obesity
• Intervention / Treatment: Dietary supplement: Resistant starch

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Recruiting
      • Purdue University
      • Contact: Jan K Green; Phone Number: 765-494-6342; Email: jkgreen@purdue.edu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistant starch; The test snack bar 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 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.
Experimental: Control; The control bar uses maltodextrin rather than 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resistant starch effects	effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing	2 weeks

Collaborators and Investigators

• Sponsor: Purdue University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 1406014929