Insulin Resistance
Conditions
Keywords
Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp
Brief 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.
Interventions
OTHERLipid Load
100mL oral lipid load
DIETARY_SUPPLEMENTWater Control
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
DIETARY_SUPPLEMENTMilk derived hydrolysate
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
DIETARY_SUPPLEMENTParent Protein
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Sponsors
Enterprise Ireland
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Disposal Rate | 12 weeks | M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Markers of glycaemic control | 12 weeks | Glucose (mmol/L) |
| Lipid Profile | 12 weeks | Non-esterified fatty acids (mmol/L) |
| Inflammatory Markers | 12 weeks | High sensitivity C reactive protein (mg/L) |
Countries
Ireland
Outcome results
None listed