NCT03102463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

February 26, 2016

Last Update Submit

August 10, 2017

Conditions

Insulin Resistance

Keywords

Insulin sensitivityObesityInsulin resistanceMilk derived hydrolysateHyperinsulinemic-euglycaemic clamp

Outcome Measures

Primary Outcomes (1)

  • Glucose Disposal Rate

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

    12 weeks

Secondary Outcomes (6)

  • Markers of glycaemic control

    12 weeks

  • Markers of glycaemic control

    12 weeks

  • Lipid Profile

    12 weeks

  • Lipid Profile

    12 weeks

  • Inflammatory Markers

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

Water Control

SHAM COMPARATOR
Dietary Supplement: Water ControlOther: Lipid Load

Milk derived hydrolysate

ACTIVE COMPARATOR
Dietary Supplement: Milk derived hydrolysateOther: Lipid Load

Parent Protein

ACTIVE COMPARATOR
Dietary Supplement: Parent ProteinOther: Lipid Load

Interventions

Water ControlDIETARY_SUPPLEMENT

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

Water Control
Milk derived hydrolysateDIETARY_SUPPLEMENT

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

Milk derived hydrolysate
Parent ProteinDIETARY_SUPPLEMENT

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

Parent Protein
Lipid LoadOTHER

100mL oral lipid load

Milk derived hydrolysateParent ProteinWater Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's University Hospital

Dublin, D4, Ireland

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helen M Roche, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 26, 2016

First Posted

April 5, 2017

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)