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| Name | Class |
|---|---|
| Reading Scientific Services Ltd. | INDUSTRY |
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The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Test Drink | Placebo Comparator | control drink |
|
| Experimental Test Drink 1 | Experimental | control drink containing ingredient 1 |
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| Experimental Test Drink 2 | Experimental | Control drink containing ingredient 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Other | 300 ml of liquid food product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-120 minutes |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Hart, SCS, Dip, MICR | RSSL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading Scientific Services Limited (RSSL) | Reading | Berkshire | RG6 6BZ | United Kingdom |
This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Test Drink/Exp Test Drink 1/Exp Test Drink 2 | Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period. Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period |
| FG001 | Exp Test Drink 1/Control Test Drink/Exp Test Drink 2 | Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period. Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period. Consume Exp Test Drink 2 once over a 15 minute period. |
| FG002 | Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1 | Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period. Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period. Consume Exp Test Drink 1 once over a 15 minute period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout Period (3 Days) |
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| Second Intervention (1 Day) |
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| Washout Period (3 Days) |
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| Third Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | mmol*min/L | 0-120 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Test Drink | Control Drink Dietary Intervention : 300 ml of liquid food product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rungano Munyuki | RSSL | +44 118 918 4166 | rungano.munyuki@rssl.com |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Dietary Intervention |
| Other |
300 ml of liquid food product |
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| Dietary Intervention | Other | 300 ml of liquid food product |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Experimental Test Drink 1 | Control Drink containing ingredient 1 Dietary Intervention : 300 ml of liquid food product |
| OG002 | Experimental Test Drink 2 | Control Drink containing ingredient 2 Dietary Intervention : 300 ml of liquid food product |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Experimental Test Drink 1 | Control Drink containing ingredient 1 Dietary Intervention : 300 ml of liquid food product | 0 | 12 | 0 | 12 |
| EG002 | Experimental Test Drink 2 | Control Drink containing ingredient 2 Dietary Intervention : 300 ml of liquid food product | 0 | 11 | 0 | 11 |
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