Blood Glucose Response of Processed Starch

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.

Detailed Description
-----------------
Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.

Official Title
-----------------
The Effect of Starch Processing on Postprandial Blood Glucose in Humans

Conditions
-----------------
Glycemic Response

Intervention / Treatment
-----------------
* Other: Commercial native starch without processing
* Other: Modified starch with extrusion processing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult males or non-pregnant females. eligible to receive income in Canada. Exclusion Criteria: age less than 18 years any known food allergies or intolerances to the investigational product medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions any major medical or surgical events requiring hospitalization within the preceding 3 months the presence of disease or drug(s) which influence digestion and absorption of nutrients the short-term use of systemic steroids or atypical antipsychotics (<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution) any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Native Starch, then Processed Starch<br>Participants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit. | Other: Commercial native starch without processing<br>* A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.<br>Other: Modified starch with extrusion processing<br>* A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.<br>|
| Experimental: Processed Starch, then Native Starch<br>Participants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit. | Other: Commercial native starch without processing<br>* A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.<br>Other: Modified starch with extrusion processing<br>* A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glycemia | Incremental area under the curve for blood glucose over 120 minutes. | -5 to 120 minutes after intervention administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Blood Glucose | Change in blood glucose from baseline at each time point | 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial Glycemia, Blood Glucose