Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2016
Date assigned
21/12/2016
Last edited
21/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Milk is an excellent source of protein and other key nutrients. Many proteins found in milk are caseins, which can be broken down into protein fragments (peptides). Bioactive peptides are protein fragments that have a beneficial effect on health. There is evidence to suggest that casein bioactive peptides have beneficial effects on health, in particular the cardiovascular (circulatory) system and immune system. Some research has suggested that milk-derived protein supplements (hydrolysates) may have potential health benefits in terms of managing blood sugar levels. The aim of this study is to examine the ability of three different types of protein drinks to help maintain good blood sugar control.

Who can participate?
Healthy adults aged between 40 and 65 years.

What does the study involve?
Participants are randomly allocated receive three treatments in a random order. Each treatment lasts for three days and there is day period between each treatment where participants follow their normal diet. The first treatment involves drinking a protein drink containing intact casein twice a day at breakfast time and in the evening for three days. The second and third treatments involve drinking a protein drink containing protein hydrolysate A and protein hydrolysate B respectively (two different milk-derived protein supplements). The study period lasts for a total of 14 days, during which participants wear a special device which automatically and continuously monitors their blood sugar levels.

What are the possible benefits and risks of participating?
There are no direct benefits to the participants but this study should help researchers gain a better understanding of how ingredients that are potentially beneficial work. There are no notable risks involved with participating.

Where is the study run from?
University College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
June 2016 to June 2018

Who is funding the study?
Enterprise Ireland (Ireland)

Who is the main contact?
Professor Lorraine Brennan

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lorraine Brennan

ORCID ID

Contact details

University College Dublin Institute of Food and Health
Dublin
D4
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CGM

Study information

Scientific title

Examination of the effect of milk proteins on glycemic management

Acronym

Study hypothesis

A protein hydrolysate will help glycemic management over and above the intact parent protein.

Ethics approval

UCD Human Ethics committee, 12/04/2016, ref: LS-16-13-Brennan

Study design

Randomised cross over intervention study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes risk

Intervention

Participants will be randomised to receive three treatments in a random order. There will be a washout period of 2 days between each arm, where participants follow their normal diet.

Treatment 1: Protein drink containing intact casein
Treatment 2: Protein drink containing protein hydrolysate A
Treatment 3: Protein drink containing protein hydrolysate B

In all treatments, the protein drink will be consumed twice daily for 3 days as part of study breakfast and evening meals.

Follow up involves wearing the FreeStyle Libre continuous glucose monitoring system for 14 days in order to monitor glucose levels.

Intervention type

Phase

Drug names

Primary outcome measures

Glucose levels are measured using the FreeStyle Libre continuous glucose monitoring system continuously for the 14 days of the study.

Secondary outcome measures

Glucose control throughout the day is measured using the FreeStyle Libre continuous monitoring system continuously for the 14 days of the study.

Overall trial start date

01/06/2016

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults aged 40-65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. BMI < 25kg/m2, BMI >35kg/m2,
2. Any diagnosis of disease or the taking of any medication (except the OCP)
3. Pregnancy or lactation
4. An allergy or intolerance to dairy or wheat products
5. Known allergy to medical grade adhesive

Recruitment start date

01/10/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Belfield
Dublin
D4
Ireland

Sponsor information

Organisation

Food for Health Ireland

Sponsor details

University College Dublin Institute of Food and Health
Dublin
D4
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Enterprise Ireland

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes