The Role of Milk Derived Peptides on Glycaemic Control

Insulin Resistance Clinical Trial

Official title:

The Role of Milk Derived Peptides on Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102463
• Other study ID #: FHI-3
• Status: Completed
• Phase: N/A
• First received: February 26, 2016
• Last updated: August 10, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Water Control
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
• Milk derived hydrolysate
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
• Parent Protein
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp

Other:
• Lipid Load
100mL oral lipid load

Locations

Country	Name	City	State
Ireland	St Vincent's University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Enterprise Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Disposal Rate	M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity	12 weeks
Secondary	Markers of glycaemic control	Glucose (mmol/L)	12 weeks
Secondary	Markers of glycaemic control	Insulin (mU/L)inflammatory markers	12 weeks
Secondary	Lipid Profile	Non-esterified fatty acids (mmol/L)	12 weeks
Secondary	Lipid Profile	Triglycerides (mmol/L) and other related lipid markers	12 weeks
Secondary	Inflammatory Markers	High sensitivity C reactive protein (mg/L)	12 weeks
Secondary	Inflammatory Markers	C-peptide (ng/mL) and other related	12 weeks

External Links

•   Study website for public information