St Vincent's University Hospital
Dublin, D4, Ireland
NCT Number: NCT03102463
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Dublin, D4, Ireland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
100mL oral lipid load
Time frame: 12 weeks
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
Time frame: 12 weeks
Glucose (mmol/L)
Time frame: 12 weeks
Insulin (mU/L)inflammatory markers
Time frame: 12 weeks
Non-esterified fatty acids (mmol/L)
Time frame: 12 weeks
Triglycerides (mmol/L) and other related lipid markers
Time frame: 12 weeks
High sensitivity C reactive protein (mg/L)
Time frame: 12 weeks
C-peptide (ng/mL) and other related
University College Dublin
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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