Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup

Study Overview
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Brief Summary
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The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

Detailed Description
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Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index. Insulinemic index is measure with the same methodology.

Official Title
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Determination of the Glycemic Index and the Insulinemic Index of a Sweetener

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Experimental sweetener syrup
* Other: Classical sweetener syrup
* Other: Classical sugar syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-50 years male healthy volunteers BMI above 25 kg/m² Exclusion Criteria: no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance food allergy kidney deficiency liver troubles gastro-intestinal troubles drugs which impair sugar and lipid metabolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|
| Experimental: Arm 2<br>Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|
| Experimental: Arm 3<br>Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|
| Experimental: Arm 4<br>Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|
| Experimental: Arm 5<br>Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|
| Experimental: Arm 6<br>Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup | Other: Experimental sweetener syrup<br>* 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sweetener syrup<br>* 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber<br>Other: Classical sugar syrup<br>* 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Index | The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate. Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above | Every 48 hours (each new intervention), over a 2 hour blood glucose challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulinemic Index | The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate. Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above | Every 48 hours (each new intervention), over a 2 hour blood glucose challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BLOOD GLUCOSE, glycemic index, rates of digestion and absorption of food