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| Name | Class |
|---|---|
| Enterprise Ireland | OTHER_GOV |
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This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve insulin resistance in cell and animal models. Therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.
Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance.
In the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. After which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water Control | Sham Comparator |
| |
| Milk derived hydrolysate | Active Comparator |
| |
| Parent Protein | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water Control | Dietary Supplement | 120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Disposal Rate | M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Markers of glycaemic control | Glucose (mmol/L) | 12 weeks |
| Markers of glycaemic control | Insulin (mU/L)inflammatory markers | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen M Roche, PhD | University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's University Hospital | Dublin | D4 | Ireland |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Milk derived hydrolysate | Dietary Supplement | Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp |
|
| Parent Protein | Dietary Supplement | Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp |
|
| Lipid Load | Other | 100mL oral lipid load |
|
| Lipid Profile | Non-esterified fatty acids (mmol/L) | 12 weeks |
| Lipid Profile | Triglycerides (mmol/L) and other related lipid markers | 12 weeks |
| Inflammatory Markers | High sensitivity C reactive protein (mg/L) | 12 weeks |
| Inflammatory Markers | C-peptide (ng/mL) and other related | 12 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |