Clinical trial NCT03102463: The Role of Milk Derived Peptides on Glycaemic Control
Official title: The Role of Milk Derived Peptides on Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin sensitivity
Obesity
Insulin resistance
Milk derived hydrolysate
Hyperinsulinemic-euglycaemic clamp
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Enterprise Ireland
First posted: 2017-04-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose Disposal Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Markers of glycaemic control
timeFrame: 12 weeks
measure: Markers of glycaemic control
timeFrame: 12 weeks
measure: Lipid Profile
timeFrame: 12 weeks
measure: Lipid Profile
timeFrame: 12 weeks
measure: Inflammatory Markers
timeFrame: 12 weeks
measure: Inflammatory Markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
Study officials:
affiliation: University College Dublin
name: Helen M Roche, PhD
role: PRINCIPAL_INVESTIGATOR
References: