Trials / Completed
CompletedNCT03102463
The Role of Milk Derived Peptides on Glycaemic Control
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University College Dublin · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Water Control | 120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp |
| DIETARY_SUPPLEMENT | Milk derived hydrolysate | Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp |
| DIETARY_SUPPLEMENT | Parent Protein | Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp |
| OTHER | Lipid Load | 100mL oral lipid load |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2017-04-05
- Last updated
- 2017-08-14
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT03102463. Inclusion in this directory is not an endorsement.