The Role of Milk Derived Peptides on Glycaemic Control

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: Water Control; Other: Lipid Load; Dietary supplement: Milk derived hydrolysate; Dietary supplement: Parent Protein

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D4
    • St Vincent's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Water Control	Dietary supplement: Water Control; 120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp; Other: Lipid Load; 100mL oral lipid load
Active Comparator: Milk derived hydrolysate	Other: Lipid Load; 100mL oral lipid load; Dietary supplement: Milk derived hydrolysate; Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Active Comparator: Parent Protein	Other: Lipid Load; 100mL oral lipid load; Dietary supplement: Parent Protein; Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers of glycaemic control	Glucose (mmol/L)	12 weeks
Markers of glycaemic control	Insulin (mU/L)inflammatory markers	12 weeks
Lipid Profile	Non-esterified fatty acids (mmol/L)	12 weeks
Lipid Profile	Triglycerides (mmol/L) and other related lipid markers	12 weeks
Inflammatory Markers	High sensitivity C reactive protein (mg/L)	12 weeks
Inflammatory Markers	C-peptide (ng/mL) and other related	12 weeks

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Enterprise Ireland
• Investigators: Principal Investigator: Helen M Roche, PhD, University College Dublin

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Insulin resistance; Insulin sensitivity; Milk derived hydrolysate; Hyperinsulinemic-euglycaemic clamp
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: FHI-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No