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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Purdue University
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT02187913
First received: July 9, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose
  • 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).

Condition Intervention
Hyperglycemia, Diabetes, and Obesity
Dietary Supplement: Resistant starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • resistant starch effects [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02187913

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Jan K Green    765-494-6342    jkgreen@purdue.edu   
Sponsors and Collaborators
Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Professor, Purdue University
ClinicalTrials.gov Identifier: NCT02187913     History of Changes
Other Study ID Numbers: 1406014929
Study First Received: July 9, 2014
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014