Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

Study Overview
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Brief Summary
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The aim of this study is develop recipes containing CHO less than ICR, prepare new snacks alternatives that could be consumed without need for additional insulin doses, and evaluate the glycemic and insulinemic responses of these recipes. A randomized crossover trial will include 15 healthy adults aged 19-30 years. All participants will consume 3 test foods and reference food (glucose solution, 2 times) in a random order. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min. Glucose and insulin analyzes will be performed from blood samples. The results of these time points will be marked on the chart and the incremental area under the curve (iAUC) will be calculated for both glucose and insulin.

Official Title
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Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

Conditions
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Healthy

Intervention / Treatment
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* Other: Blueberry Cake
* Other: Snacks with Cheese
* Other: Spicy Crackers
* Other: Glucose Solution First Repeat
* Other: Glucose Solution Second Repeat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer Normal body weight (18.5-25 kg / m2 BMI) 19-30 years old Exclusion Criteria: use of tobacco, weight change of >5 kg in the last 3 months the presence of any chronic disease or lactose intolerance, regular medicine use, pregnancy or lactation, performing competitive sports or endurance sports, fasting plasma glucose concentration >100 mg / dL, the presence of eating disorder, sensitivity or allergies to any food that used in the study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Foods<br>Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods. | Other: Blueberry Cake<br>* Blueberry cake containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.<br>Other: Snacks with Cheese<br>* Snacks with cheese containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.<br>Other: Spicy Crackers<br>* Spicy crackers containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.<br>|
| Experimental: Reference Food<br>Glucose solution will use as reference food. | Other: Glucose Solution First Repeat<br>* The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.<br>Other: Glucose Solution Second Repeat<br>* The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose response | Postprandial glucose response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. | two hours postprandial period | 
| Postprandial insulin response | Postprandial insulin response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. | two hours postprandial period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic index, Insulinemic index, Low carbohydrate, Snack, Type 1 diabetes