The Role of Milk Derived Peptides on Glycaemic Control

University College Dublin

Status: Completed

Conditions: Insulin Resistance

Treatments: Dietary Supplement: Water Control; Dietary Supplement: Milk derived hydrolysate; Dietary Supplement: Parent Protein; Other: Lipid Load

Study type: Interventional

Funder types: Other

Identifiers

NCT03102463

FHI-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Water Control

Sham Comparator group

Treatment:

Other: Lipid Load

Dietary Supplement: Water Control

Milk derived hydrolysate

Active Comparator group

Treatment:

Other: Lipid Load

Dietary Supplement: Milk derived hydrolysate

Parent Protein

Active Comparator group

Treatment:

Other: Lipid Load

Dietary Supplement: Parent Protein