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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics: 71/08 |
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The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.
It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.
The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein native | Experimental | Whey protein native versus the 6 other arms |
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| Whey protein microgels | Experimental | Whey protein microgels versus the 6 other arms |
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| Hydrolyzed whey protein | Experimental | Hydrolyzed whey protein versus the 6 other arms |
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| Casein native | Experimental | Casein native versus the 6 other arms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein native | Other | Whey protein native against the 6 other arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Plasma Responses of Glucose Concentrations | The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline. | 180 minutes |
| Calculation of the Area Under Curve Over Baseline for Plasma Insulin | The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline. | 180 minutes from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids | 180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne Pouteau, Ph.D. | Société des Produits Nestlé (SPN) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nestec Clinical Development Unit / Metabolic Unit | Lausanne | 1000 | Switzerland |
25 healthy males were recruited; All presented all the inclusion criteria and none of the exclusion criteria listed in the protocol. The day before each test meal, the volunteers were recommended to eat normally as well as to conduct a normal physical activity. A standardized dinner was provided the night before testing.
Participants were recruited among the Nestlé Research Center staff from June 2008 to May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 7 Proteins Were Tested Randomly | Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 2nd Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 3rd Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 4th Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 5th Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 6th Protein Testing (1 Day) |
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| Washout (7 Days) |
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| 7th and Last Protein Testing (1 Day) |
|
Participants were recruited amoung the Nestlé Research Center staff.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive 7 products in a randomized series |
| 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 | Post-prandial Plasma Responses of Glucose Concentrations | The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline. | 23 subjects were investigated for AUC of glucose calculations | Posted | Mean | Standard Error | mmole/L*min | 180 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 | Whey Protein Native | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maurice Beaumont | Clinical Development Unit / Metabolic Unit | +41217858054 | maurice.beaumont@rdls.nestle.com |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Hydrolyzed casein |
| Experimental |
Hydrolyzed casein versus the 6 other arms |
|
| Total milk protein native | Experimental | Total milk protein native versus the 6 other arms |
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| Hydrolyzed milk protein | Experimental | Hydrolyzed milk protein versus the 6 other arms |
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| Whey protein microgels | Other | Whey protein microgels versus the six other arms |
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| Hydrolyzed whey protein | Other | versus the six other arms |
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| Casein native | Other | versus the six other arms |
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| Hydrolyzed casein | Other | versus the six other arms |
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| Total milk protein native | Other | versus the six other arms |
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| Hydrolyzed milk protein | Other | versus the six other arms |
|
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| Years |
|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | BMI is obtained by dividing the weight (kg) by the square height (m2) | Mean | Standard Deviation | kg/m2 |
|
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
| OG002 | Hydrolyzed Whey Protein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
| OG003 | Casein Native | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
| OG004 | Hydrolyzed Casein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
| OG005 | Total Milk Protein Native | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
| OG006 | Hydrolyzed Milk Protein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. |
|
|
| Secondary | Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids | Not Posted | 180 minutes |
| Primary | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline. | Posted | Mean | Standard Error | nmole/L*min | 180 minutes from baseline |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Whey Protein Microgels | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 24 | 0 | 24 |
| EG002 | Hydrolyzed Whey Protein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 23 | 0 | 23 |
| EG003 | Casein Native | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 24 | 0 | 24 |
| EG004 | Hydrolyzed Casein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 24 | 0 | 24 |
| EG005 | Total Milk Protein Native | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 23 | 0 | 23 |
| EG006 | Hydrolyzed Milk Protein | High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. | 0 | 23 | 0 | 23 |
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