Glycemic Index, Glycemic Response
Conditions
Brief summary
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
Interventions
OTHERDietary Intervention
300 ml of liquid food product
Sponsors
Reading Scientific Services Ltd.
Mondelēz International, Inc.
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% males or females * Non-smoker * Aged 18 to 55 years * Have a body mass index between 18.5 to 29.99 kg/m2 * Healthy, non-diabetic, no gastric bypass surgery * Not allergic to mustard, dairy or soy * Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L) * Willing and able to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products | 0-120 minutes | The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 11 subjects completed the study. The study was conducted at one clinical research site and study started February, 2012 and was completed in March 2012.
Pre-assignment details
This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Washout Period (3 Days) | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 11 |
Outcome results
Primary
Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products
The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.
Time frame: 0-120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Test Drink | Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products | 100 mmol*min/L | Standard Error 17 |
| Experimental Test Drink 1 | Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products | 68 mmol*min/L | Standard Error 10 |
| Experimental Test Drink 2 | Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products | 73 mmol*min/L | Standard Error 13 |