Back to resultsThe Role of Milk Derived Peptides on Glycaemic Control
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Water Control
Milk derived hydrolysate
Parent Protein
Lipid Load
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp
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.
Sites / Locations
- St Vincent's University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Active Comparator
Arm Label
Water Control
Milk derived hydrolysate
Parent Protein
Arm Description
Outcomes
Primary Outcome Measures
Glucose Disposal Rate
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
Secondary Outcome Measures
Markers of glycaemic control
Glucose (mmol/L)
Markers of glycaemic control
Insulin (mU/L)inflammatory markers
Lipid Profile
Non-esterified fatty acids (mmol/L)
Lipid Profile
Triglycerides (mmol/L) and other related lipid markers
Inflammatory Markers
High sensitivity C reactive protein (mg/L)
Inflammatory Markers
C-peptide (ng/mL) and other related
Full Information
NCT ID
NCT03102463
First Posted
February 26, 2016
Last Updated
August 10, 2017
Sponsor
University College Dublin
Collaborators
Enterprise Ireland
1. Study Identification
Unique Protocol Identification Number
NCT03102463
Brief Title
The Role of Milk Derived Peptides on Glycaemic Control
Official Title
The Role of Milk Derived Peptides on Glycaemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
Enterprise Ireland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water Control
Arm Type
Sham Comparator
Arm Title
Milk derived hydrolysate
Arm Type
Active Comparator
Arm Title
Parent Protein
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Water Control
Intervention Description
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk derived hydrolysate
Intervention Description
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Intervention Type
Dietary Supplement
Intervention Name(s)
Parent Protein
Intervention Description
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Intervention Type
Other
Intervention Name(s)
Lipid Load
Intervention Description
100mL oral lipid load
Primary Outcome Measure Information:
Title
Glucose Disposal Rate
Description
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Markers of glycaemic control
Description
Glucose (mmol/L)
Time Frame
12 weeks
Title
Markers of glycaemic control
Description
Insulin (mU/L)inflammatory markers
Time Frame
12 weeks
Title
Lipid Profile
Description
Non-esterified fatty acids (mmol/L)
Time Frame
12 weeks
Title
Lipid Profile
Description
Triglycerides (mmol/L) and other related lipid markers
Time Frame
12 weeks
Title
Inflammatory Markers
Description
High sensitivity C reactive protein (mg/L)
Time Frame
12 weeks
Title
Inflammatory Markers
Description
C-peptide (ng/mL) and other related
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Roche, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D4
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Milk Derived Peptides on Glycaemic Control
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