Healthy
Conditions
Keywords
glycemic index
Brief summary
The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.
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.
Interventions
OTHERGlucose100
OTHERGlucose50
OTHERGlucose42
OTHEROral 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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Percent Fat Mass | Baseline | Percent fat mass at baseline 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. |
Countries
United States
Outcome results
None listed