Reduction of Post-prandial Glycaemic Response
Conditions
Brief summary
The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response
Detailed description
This is a two treatment randomized double-blind crossover study, with each test product replicated twice. Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order. Washout: 2 days or more (may return on day 3) Run-in: High carbohydrate diet guidance (\>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required) Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments) Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.
Interventions
OTHERD-fagomine
Measure the changes produced on the postprandial Glycaemic response
Sponsors
Bioglane
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female (not less than 40% Male) * Aged 18 - 55 years * Have a body mass index between 18.5 to 29.99 kg/m2 * Healthy, non-diabetic, no gastric bypass surgery * Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L) * Willing and able to provide written informed consent
Exclusion criteria
* Smokers * Allergic to dairy or soy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glycaemic Response Index | 120 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Blood Glucose Concentration (C Max) Over the Baseline | Usually in the range of 30-45 minutes | Determine 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) |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment of adults volunteers done by RSSL, in Reading (United Kingdom), under GCP.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| D-fagomine (All Study 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | D-fagomine (All Study Participants) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 39.8 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United Kingdom | 14 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Postprandial Glycaemic Response Index
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.
Time frame: 120 minutes
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Change D-fagomine/Control AUC at 60 Min | Postprandial Glycaemic Response Index | 73.28 percentage of AUC fagomine/AUC control |
| Change D-fagomine/Control AUC at 120 Min | Postprandial Glycaemic Response Index | 83.45 percentage of AUC fagomine/AUC control |
p-value: <0.0001ANOVA
p-value: <0.016ANOVA
Secondary
Maximum Blood Glucose Concentration (C Max) Over the Baseline
Determine 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)
Time frame: Usually in the range of 30-45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change D-fagomine/Control AUC at 60 Min | Maximum Blood Glucose Concentration (C Max) Over the Baseline | 2.3 mmol/L | Standard Error 0.19 |
| Change D-fagomine/Control AUC at 120 Min | Maximum Blood Glucose Concentration (C Max) Over the Baseline | 3.6 mmol/L | Standard Error 0.37 |