NCT02187913

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

July 9, 2014

Last Update Submit

July 10, 2014

Conditions

Hyperglycemia, Diabetes, and Obesity

Outcome Measures

Primary Outcomes (1)

  • resistant starch effects

    effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing

    2 weeks

Study Arms (2)

Resistant starch

EXPERIMENTAL

The test snack bar consumed has the resistant starch

Dietary Supplement: Resistant starch

Control

EXPERIMENTAL

The control bar uses maltodextrin rather than the resistant starch.

Dietary Supplement: Resistant starch

Interventions

Resistant starchDIETARY_SUPPLEMENT

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.

ControlResistant starch

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusObesity

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

US(1)