Healthy Volunteers
Conditions
Keywords
BLOOD GLUCOSE, glycemic index, rates of digestion and absorption of food
Brief summary
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup
Detailed description
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.
Interventions
OTHERExperimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
OTHERClassical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
OTHERClassical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Sponsors
Routin SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Index | Every 48 hours (each new intervention), over a 2 hour blood glucose challenge | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulinemic Index | Every 48 hours (each new intervention), over a 2 hour blood glucose challenge | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Each subject received the study products in different order according to the randomization list | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 23.7 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment France | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 4 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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
Time frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Classical Sugar Syrup | Glycemic Index | 100 % of GI of the glucose | Standard Deviation 0 |
| Experimental Sweetener Syrup | Glycemic Index | 33.68 % of GI of the glucose | Standard Deviation 20.28 |
| Classical Sweetener Syrup | Glycemic Index | 12.83 % of GI of the glucose | Standard Deviation 14.74 |
Secondary
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
Time frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Classical Sugar Syrup | Insulinemic Index | 100 % of the GI of the glucose | Standard Deviation 0 |
| Experimental Sweetener Syrup | Insulinemic Index | 34.28 % of the GI of the glucose | Standard Deviation 16.57 |
| Classical Sweetener Syrup | Insulinemic Index | 17.38 % of the GI of the glucose | Standard Deviation 14.09 |