Trial Outcomes & Findings for Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup (NCT NCT00717912)
NCT ID: NCT00717912
Last Updated: 2017-07-13
Results Overview
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
COMPLETED
NA
6 participants
Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
2017-07-13
Participant Flow
Participant milestones
| Measure |
Arm 1
Classical sugar syrup/ Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
|
Arm 2
Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
|
Arm 3
Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
|
Arm 4
Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
|
Arm 5
Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
|
Arm 6
Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
Each subject received the study products in different order according to the randomization list
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 48 hours (each new intervention), over a 2 hour blood glucose challengeThe 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
Outcome measures
| Measure |
Classical Sugar Syrup
n=6 Participants
The subjects consumed three time this product
|
Experimental Sweetener Syrup
n=6 Participants
The subjects consumed three times this product
|
Classical Sweetener Syrup
n=6 Participants
The subjects consumed once this product
|
|---|---|---|---|
|
Glycemic Index
|
100 % of GI of the glucose
Standard Deviation 0
|
33.68 % of GI of the glucose
Standard Deviation 20.28
|
12.83 % of GI of the glucose
Standard Deviation 14.74
|
SECONDARY outcome
Timeframe: Every 48 hours (each new intervention), over a 2 hour blood glucose challengeThe 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
Outcome measures
| Measure |
Classical Sugar Syrup
n=6 Participants
The subjects consumed three time this product
|
Experimental Sweetener Syrup
n=6 Participants
The subjects consumed three times this product
|
Classical Sweetener Syrup
n=6 Participants
The subjects consumed once this product
|
|---|---|---|---|
|
Insulinemic Index
|
100 % of the GI of the glucose
Standard Deviation 0
|
34.28 % of the GI of the glucose
Standard Deviation 16.57
|
17.38 % of the GI of the glucose
Standard Deviation 14.09
|
Adverse Events
Classical Sugar Syrup
Experimental Sweetener Syrup
Classical Sweetener Syrup
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Classical Sugar Syrup
n=6 participants at risk
The subjects consumed three times this product
|
Experimental Sweetener Syrup
n=6 participants at risk
The subjects consumed three times this product
|
Classical Sweetener Syrup
n=6 participants at risk
The subjects consumed once this product
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60