Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| pfact 9806 | Other Identifier | Oxford Brookes University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roquette Freres | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.
The aims of this study were to examine:
Phase I - the glycaemic response (GR) and insulinaemic response (IR) to:
Phase II - the GLP-1 and GIP response to:
A single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose | Placebo Comparator | Glucose - 50 g |
|
| Nutralys S85 Plus 25 g | Experimental | Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose |
|
| Nutralys S85 Plus 50 g | Experimental | Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 g Nutralys Pea Protein | Dietary Supplement | To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose response from baseline for 3 hours | Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours |
| Change in plasma insulin response from baseline for 3 hours | Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours |
| Area under the blood glucose concentration versus time curve | Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule | 3 hours |
| Area under the plasma insulin concentration versus time curve | Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule | 3 hours |
| Peak blood glucose concentration (Cmax) | Peak blood glucose concentration (Cmax) after consumption of the test food | 0-3 hours |
| Peak plasma insulin concentration (Cmax) | Peak plasma insulin concentration (Cmax) after consumption of the test food | 0-3 hours |
| Time of blood glucose peak (Tmax) | Time of blood glucose peak after consumption of the test food | 0-3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GLP-1 from baseline for 3 hours | Change in GLP-1 from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours | 3 hours |
| Change in GIP from baseline for 3 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sangeetha Thondre, PhD | Oxford Brookes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Brookes Centre for Nutrition and Health | Oxford | OX3 0BP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20359723 | Background | Siahanidou T, Margeli A, Kappis A, Papassotiriou I, Mandyla H. Circulating visfatin levels in healthy preterm infants are independently associated with high-density lipoprotein cholesterol levels and dietary long-chain polyunsaturated fatty acids. Metabolism. 2011 Mar;60(3):389-93. doi: 10.1016/j.metabol.2010.03.002. Epub 2010 Mar 31. |
| Label | URL |
|---|---|
| 23\. Food Products-Determination of the glycaemic index (GI) and recommendation for food classification. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 | Oct 10, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2018 | Oct 10, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
randomised, repeat measure, crossover design trial
Not provided
Not provided
single-blind
| 50 g Nutralys S85 Plus. | Dietary Supplement | To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus . |
|
| 50 g Glucose | Dietary Supplement | To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose |
|
| Time of plasma insulin peak (Tmax) | Time of plasma insulin peak after consumption of the test food | 0-3 hours |
Change in GIP from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours
| 3 hours |
| Area under the plasma GLP-1 concentration versus time curve | Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule | 3 hours |
| Area under the plasma GIP concentration versus time curve | Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule | 3 hours |
| Peak plasma GLP-1 concentration (Cmax) | Peak plasma GLP-1 concentration (Cmax) after consumption of the test food | 0-3 hours |
| Peak plasma GIP concentration (Cmax) | Peak plasma GIP concentration (Cmax) after consumption of the test food | 0-3 hours |
| Time of plasma GLP-1 peak (Tmax) | Time of plasma GLP-1 peak after consumption of the test food | 0-3 hours |
| Time of plasma GIP peak (Tmax) | Time of plasma GIP peak after consumption of the test food | 0-3 hours |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| Individual Participant Data Set | View IPD |
| Statistical Analysis Plan | View IPD | Included in the Study Protocol and Clinical Study report |