The Role of Milk Derived Peptides on Glycaemic Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College Dublin
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Glucose Disposal Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Water Control
Intervention: Water Control (Dietary Supplement)
Water Control
Intervention: Lipid Load (Other)
Milk derived hydrolysate
Intervention: Milk derived hydrolysate (Dietary Supplement)
Milk derived hydrolysate
Intervention: Lipid Load (Other)
Parent Protein
Intervention: Parent Protein (Dietary Supplement)
Parent Protein
Intervention: Lipid Load (Other)
Outcomes
Primary Outcomes
Glucose Disposal Rate
Time Frame: 12 weeks
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
Secondary Outcomes
- Markers of glycaemic control(12 weeks)
- Lipid Profile(12 weeks)
- Inflammatory Markers(12 weeks)
Investigators
Prof Helen M Roche
Associate Professor
University College Dublin