Comparison of Different Types of Resistant Starch

Study Overview
=================
Brief Summary
-----------------
This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

Detailed Description
-----------------
Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration. In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).

Official Title
-----------------
Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose

Conditions
-----------------
Postprandial Hyperglycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Resistant Starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apparently healthy Exclusion Criteria: diagnosis of any chronic disease wheat allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose<br>30 g of carbohydrate via Sun-Dex OGTT beverage | Dietary Supplement: Resistant Starch<br>* 30 g of carbohydrate per Arm<br>* Other names: Fibersym RW;|
| Experimental: RS Type 2<br>30g Resistant Starch Type 2 (Hi-Maize 260, National Starch) | Dietary Supplement: Resistant Starch<br>* 30 g of carbohydrate per Arm<br>* Other names: Fibersym RW;|
| Experimental: RS Type 4 (cross linked)<br>30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.) | Dietary Supplement: Resistant Starch<br>* 30 g of carbohydrate per Arm<br>* Other names: Fibersym RW;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain