The Role of Milk Derived Peptides on Glycaemic Control

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Dietary Supplement: Parent Protein; Dietary Supplement: Water Control; Dietary Supplement: Milk derived hydrolysate; Other: Lipid Load

• Registration Number: NCT03102463
• Lead Sponsor: University College Dublin

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Parent Protein	Parent Protein	-
Water Control	Water Control	-
Milk derived hydrolysate	Milk derived hydrolysate	-
Milk derived hydrolysate	Lipid Load	-
Water Control	Lipid Load	-
Parent Protein	Lipid Load	-

Primary Outcome Measures

Name	Time	Method
Glucose Disposal Rate	12 weeks	M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
Markers of glycaemic control	12 weeks	Insulin (mU/L)inflammatory markers
Inflammatory Markers	12 weeks	C-peptide (ng/mL) and other related
Lipid Profile	12 weeks	Triglycerides (mmol/L) and other related lipid markers

Trial Locations

Locations (1)

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland