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| ID | Type | Description | Link |
|---|---|---|---|
| RH01899 | Other Identifier | GSK |
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The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water |
|
| Placebo | Placebo Comparator | No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25% fibre | Dietary Supplement | Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Glucose in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG) | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for Triglyceride in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for Glucose in Overweight Healthy Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lambda Therapeutic Research Ltd | Ahmedabad | Gujarat | 380 061 | India |
Of the 210 participants screened, 114 participants were not randomised. The reasons for the same were: not meeting study criteria (n=42), lost to follow-up (n=5), and other reasons (n=67).
Participants were mainly recruited from the study site database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water. |
| FG001 | Sequence 2 | Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cmax for Glucose in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG) | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
Adverse events were recorded from the start of the investigational product, and until one day following last administration of the investigational product.
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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 | Test | Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| 0% fibre | Dietary Supplement | Placebo is an energy matched powdered beverage |
|
To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults |
| Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for Triglyceride in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Cmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| AUC for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| Tmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Impaired fasting glucose (IFG) status | Number | participants |
|
| OG001 | Placebo | No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water. |
|
|
|
| Primary | Cmax for Triglyceride in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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|
|
| Secondary | Cmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | AUC for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg*min/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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| Secondary | Tmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | Cmax for Triglyceride in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | AUC for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mg*min/dL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | Tmax for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | Cmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mmole/L | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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|
| Secondary | AUC for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mmole*min/L | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | Tmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
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|
| Secondary | Cmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mmole/L | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| Secondary | AUC for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | mmole*min/L | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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|
| Secondary | Tmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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| Secondary | Cmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | µIU/mL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
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| Secondary | AUC for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | µIU*min/mL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
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| Secondary | Tmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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| Secondary | Cmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | µIU/mL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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| Secondary | AUC for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | µIU*min/mL | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
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| Secondary | Tmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults | The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation. | Posted | Mean | Standard Deviation | minutes | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes |
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Placebo | No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water. | 0 | 96 | 1 | 96 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| Superiority or Other |