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Completed

NCT Number: NCT03102463

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's University Hospital

Dublin, D4, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water Control

Dietary Supplement

120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp

Milk derived hydrolysate

Dietary Supplement

Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp

Parent Protein

Dietary Supplement

Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp

Lipid Load

Other

100mL oral lipid load

Primary outcomes

  1. Glucose Disposal Rate

    Time frame: 12 weeks

    M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity

Secondary outcomes

  1. Markers of glycaemic control

    Time frame: 12 weeks

    Glucose (mmol/L)

  2. Markers of glycaemic control

    Time frame: 12 weeks

    Insulin (mU/L)inflammatory markers

  3. Lipid Profile

    Time frame: 12 weeks

    Non-esterified fatty acids (mmol/L)

  4. Lipid Profile

    Time frame: 12 weeks

    Triglycerides (mmol/L) and other related lipid markers

  5. Inflammatory Markers

    Time frame: 12 weeks

    High sensitivity C reactive protein (mg/L)

  6. Inflammatory Markers

    Time frame: 12 weeks

    C-peptide (ng/mL) and other related

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Enterprise Ireland

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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