The Role of Milk Derived Peptides on Glycaemic Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Role of Milk Derived Peptides on Glycaemic Control

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Water Control
* Dietary Supplement: Milk derived hydrolysate
* Dietary Supplement: Parent Protein
* Other: Lipid Load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65 years BMI > 26 kg/m2 Prepared to maintain a constant body weight for the duration of the study Free of any chronic or infectious disease Not taking any medication for the regulation of blood sugars Diet controlled type 2 diabetes Free of any milk allergies or lactose intolerance Without anaemia Exclusion Criteria: <18 or >65 years Diabetes (pharmacologically treated) or other endocrine disorders. Chronic inflammatory conditions. Kidney or liver dysfunction. Anaemia (Haemoglobin <12g/dl men, < 11g/dl women). Taking any medication for the regulation of blood sugars.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Water Control<br> | Dietary Supplement: Water Control<br>* 120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp<br>Other: Lipid Load<br>* 100mL oral lipid load<br>|
| Active Comparator: Milk derived hydrolysate<br> | Dietary Supplement: Milk derived hydrolysate<br>* Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp<br>Other: Lipid Load<br>* 100mL oral lipid load<br>|
| Active Comparator: Parent Protein<br> | Dietary Supplement: Parent Protein<br>* Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp<br>Other: Lipid Load<br>* 100mL oral lipid load<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of glycaemic control | Glucose (mmol/L) | 12 weeks | 
| Markers of glycaemic control | Insulin (mU/L)inflammatory markers | 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp