Condition category
Not Applicable
Date applied
05/12/2014
Date assigned
13/04/2015
Last edited
14/04/2015
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 nutrients. Many proteins found in milk are caseins. These can be broken down into protein fragments, or 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, for example, the cardiovascular system (for example, lowering blood pressure), immune system and nervous system. However, to fully understand these effects we need to find out how many of these bioactive peptides are available for use by the body once consumed. This study aims to achieve a greater understanding of the behaviour of a bioactive casein hydrolysate by examining the appearance of metabolic products in the circulation in a group of healthy individual’s.

Who can participate?
Healthy Caucasian adults aged 18-65 years

What does the study involve?
Participants are randomly allocated to consume one of three test drinks (labelled caseins containing bioactive peptides, labelled caseins that have not been broken down, or unlabelled caseins) on three separate test days in random order. After fasting overnight, blood samples are taken from each participant over a period of 4 hours. Participants then come back for a second and third visit so that all drinks will have been consumed in random order by the end of the study.

What are the possible benefits and risks of participating?
There are no direct benefits to the participant, rather this study is to help researchers gain a better understanding of how ingredients that are potentially beneficial work.

Where is the study run from?
UCD Institute of Food and Health at University College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
December 2014 to December 2018

Who is funding the study?
Food for Health (Ireland)

Who is the main contact?
Dr Lorraine Brennan
lorraine.brennan@ucd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorraine Brennan

ORCID ID

http://orcid.org/0000-0002-7711-7499

Contact details

UCD
Belfield
Dublin 4
D4
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Investigating the metabolic end products of casein-derived bioactive peptides

Acronym

FHIGM

Study hypothesis

To identify metabolic end products after consumption of milk casein-derived bioactive peptides

Ethics approval

Human Research Ethics Committee in University College Dublin (UCD), 17/10/14, ref: LS-14-34-Drummond-Brennan.

Study design

This is a randomised, crossover dietary intervention study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Healthy subjects

Intervention

Participants will be randomised to receive the three test drinks (labelled caseins containing bioactive peptides, labelled caseins that have not been broken down, or unlabelled caseins) in random order, in a crossover fashion.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Appearance of casein-derived metabolites and fragments thereof in the plasma postprandially.

Study subjects will attend the intervention suites in our research centre. At time 0, 10, 15, 30, 60, 90, 120, 180 and 240 minutes blood samples will be collected. Analysis will be performed at all timepoints.

Secondary outcome measures

Postprandial dietary nitrogen metabolism and hormonal profiles.

Overall trial start date

05/12/2014

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male and females free-living Caucasians aged 18-65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. A body mass index (BMI) <18.0 or >31.0 (kg/m2),
2. Any chronic or infectious disease
3. Any prescribed medication (contraceptive pills and hormone replacement therapy will be permitted)
4. Pregnant or lactating females

Recruitment start date

01/01/2015

Recruitment end date

01/01/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

UCD Institute of Food and Health
Dublin
Ireland

Sponsor information

Organisation

Food for Health Ireland

Sponsor details

UCD Institute of Food and Health
Level 2
Science Centre South
UCD
Dublin 4
D4
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Food for Health (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is intended that the results of this study will be published in an academic journal.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes