Glycemic Index of Commonly Consumed Sweeteners
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Glucose100 Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits. |
Other: Glucose100
Other: Oral Glucose Tolerance Test
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.
Other Names:
|
| Active Comparator: Glucose50 Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits. |
Other: Glucose50
Other: Oral Glucose Tolerance Test
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.
Other Names:
|
| Active Comparator: Glucose42 Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits. |
Other: Glucose42
Other: Oral Glucose Tolerance Test
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Glycemic Index [2 hours]
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)
Secondary Outcome Measures
- Body Mass Index (BMI) [Baseline]
BMI will be captured at the baseline visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters)
- Body Mass Index (BMI) [9 weeks]
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)
- Percent Fat Mass [Baseline]
Percent fat mass at baseline will be captured using the Tanita Body Fat Analyzer.
- Percent Fat Mass [9 weeks]
Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.
- Total Fat Mass [Baseline]
Total fat mass at baseline will be captured using the Tanita Body Fat Analyzer.
- Total Fat Mass [9 weeks]
Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.
Eligibility Criteria
Criteria
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
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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
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medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
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no major medical or surgical event requiring hospitalization in the past 3 months
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no disease or drugs that influence digestion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale Center for Clinical Investigation Church Street Research Unit | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Yale University
Investigators
- Principal Investigator: Eugene Shapiro, MD, Yale School of Medicine
- Principal Investigator: Ania M Jastreboff, MD, PhD, Yale School of Medicine
- Principal Investigator: Robert S Sherwin, MD, Yale School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 1604017520