Recruiting

Resistant Starch

Sponsor:

Purdue University

Code:

NCT02187913

Conditions

Hyperglycemia, Diabetes, and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Interventions

Resistant starch

Study Details

Brief 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).

Conditions

Hyperglycemia, Diabetes, and Obesity

Study ID

NCT02187913

Start date

Jul, 2014

Status verified date

Jul, 2014

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Resistant starch

The test snack bar consumed has the resistant starch

experimental: Control

The control bar uses maltodextrin rather than the resistant starch.

Interventions

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.

Primary outcome measure

  • resistant starch effects [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Jan K Green

765-494-6342jkgreen@purdue.edu

More Information

Sponsor

Purdue University

Last update posted

Jul 11, 2014

Last verified

Jul, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2014-07-11.