Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2015-10-31
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Water Control
Water Control
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
Lipid Load
100mL oral lipid load
Milk derived hydrolysate
Milk derived hydrolysate
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Lipid Load
100mL oral lipid load
Parent Protein
Parent Protein
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Lipid Load
100mL oral lipid load
Interventions
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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
Lipid Load
100mL oral lipid load
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Enterprise Ireland
OTHER_GOV
University College Dublin
OTHER
Responsible Party
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Prof Helen M Roche
Associate Professor
Principal Investigators
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Helen M Roche, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Locations
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St Vincent's University Hospital
Dublin, , Ireland
Countries
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Other Identifiers
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FHI-3
Identifier Type: -
Identifier Source: org_study_id
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