Trial Outcomes & Findings for Effects of Added D-fagomine on Glycaemic Responses to Sucrose (NCT NCT01811303)
NCT ID: NCT01811303
Last Updated: 2023-09-18
Results Overview
On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.
COMPLETED
NA
14 participants
120 minutes
2023-09-18
Participant Flow
Recruitment of adults volunteers done by RSSL, in Reading (United Kingdom), under GCP.
There was 15 subjects screened that all were complying with the eligibility criteria. Finally only 14 subjects were involved in the study and analysed as far the study was planned to involve 12 subjects. All 14 subjects received the treatment randomized to a William's Latin square design balanced for treatment order.
Participant milestones
| Measure |
Placebo, Placebo, Treatment, Treatment
The subjects receive placebo in the first two interventions.
|
Treatment, Treatment, Placebo, Placebo
The subjects receive treatment in the first two interventions
|
Placebo, Treatment, Placebo, Treatment
The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
|
Treatment, Placebo, Treatment, Placebo
The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
4
|
4
|
4
|
2
|
|
First Intervention (1 Day)
COMPLETED
|
4
|
4
|
4
|
2
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (2 Days or More)
STARTED
|
4
|
4
|
4
|
2
|
|
Washout (2 Days or More)
COMPLETED
|
4
|
4
|
4
|
2
|
|
Washout (2 Days or More)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
4
|
4
|
4
|
2
|
|
Second Intervention (1 Day)
COMPLETED
|
4
|
4
|
4
|
2
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Day)
STARTED
|
4
|
4
|
4
|
2
|
|
Third Intervention (1 Day)
COMPLETED
|
4
|
4
|
4
|
2
|
|
Third Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Intervention (1 Day)
STARTED
|
4
|
4
|
4
|
2
|
|
Fourth Intervention (1 Day)
COMPLETED
|
4
|
4
|
4
|
2
|
|
Fourth Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Added D-fagomine on Glycaemic Responses to Sucrose
Baseline characteristics by cohort
| Measure |
D-fagomine (All Study Participants)
n=14 Participants
Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 minutesPopulation: The number of participants \>10, the repetitions \>= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145-171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.
On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.
Outcome measures
| Measure |
Change D-fagomine/Control AUC at 60 Min
n=14 Participants
Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
|
Change D-fagomine/Control AUC at 120 Min
n=14 Participants
Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
|
|---|---|---|
|
Postprandial Glycaemic Response Index
|
73.28 percentage of AUC fagomine/AUC control
Interval 63.66 to 82.9
|
83.45 percentage of AUC fagomine/AUC control
Interval 67.73 to 99.17
|
SECONDARY outcome
Timeframe: Usually in the range of 30-45 minutesDetermine the glucose C max of Sucrose with D-fagomine over the baseline. The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline. Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)
Outcome measures
| Measure |
Change D-fagomine/Control AUC at 60 Min
n=14 Participants
Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
|
Change D-fagomine/Control AUC at 120 Min
n=14 Participants
Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
|
|---|---|---|
|
Maximum Blood Glucose Concentration (C Max) Over the Baseline
|
2.3 mmol/L
Standard Error 0.19
|
3.6 mmol/L
Standard Error 0.37
|
Adverse Events
D-fagomine (All Study Participants)
Placebo - Control (All Study Participants)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rungano Munyuki (Clinical Project Manager)
RSSL
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place