Glycemic Index of Commonly Consumed Sweeteners

Study Overview
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Brief Summary
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The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.

Detailed Description
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This three arm study is intended to add to scientific knowledge by providing accurate assessments of the glycemic index commonly consumed food items. This will be used in the scientific literature to assess the glycemic index of foods containing various sweeteners. Participants will be monitored for a total of 10 weeks. The glycemic index is defined as the incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed. In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.

Official Title
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Glycemic Index of Commonly Consumed Sweeteners

Conditions
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Healthy

Intervention / Treatment
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* Other: Glucose100
* Other: Glucose50
* Other: Glucose42
* Other: Oral Glucose Tolerance Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18.5-24.9 (lean) no medications no weight changes over the previous 6 months (defined as >=10% change in body weight) Exclusion Criteria: current active participation in a weight loss program (dietary or physical activity focused) prior bariatric surgery significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes women who are pregnant or lactating medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals) no major medical or surgical event requiring hospitalization in the past 3 months no disease or drugs that influence digestion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose100<br>Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits. | Other: Glucose100<br> <br> Other: Oral Glucose Tolerance Test<br>* For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.<br>* Other names: OGTT;|
| Active Comparator: Glucose50<br>Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits. | Other: Glucose50<br> <br> Other: Oral Glucose Tolerance Test<br>* For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.<br>* Other names: OGTT;|
| Active Comparator: Glucose42<br>Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits. | Other: Glucose42<br> <br> Other: Oral Glucose Tolerance Test<br>* For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.<br>* Other names: OGTT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glycemic Index | The mean glycemic index of participants will be calculated by averaging the 3 calculated glycemic index values for each of the 3 types of sweetener. Each participant will be randomly given 1 of 3 the commonly consumed sweeteners three different times over a nine week period- for a total of 3 observations per arm. Glycemic index is measured by giving test subjects the commonly consumed sweetener, and then measuring blood glucose response over a two hour time period using an Oral Glucose Tolerance Test. That response is then compared against a reference (glucose) and averaged across all subjects to get a relative index value. The glycemic index (GI) is a ranking of carbohydrates on a scale from 0 to 100 according to the extent to which they raise blood sugar levels after eating. (http://www.glycemicindex.com/about.php) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | BMI will be captured at the baseline visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters) | Baseline | 
| Body Mass Index (BMI) | BMI will be captured at the 9 weeks visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters) | 9 weeks | 
| Percent Fat Mass | Percent fat mass at baseline will be captured using the Tanita Body Fat Analyzer. | Baseline | 
| Percent Fat Mass | Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer. | 9 weeks | 
| Total Fat Mass | Total fat mass at baseline will be captured using the Tanita Body Fat Analyzer. | Baseline | 
| Total Fat Mass | Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycemic index