A study of the biological availability of protein-derived ingredients

ISRCTN	ISRCTN17379716
DOI	https://doi.org/10.1186/ISRCTN17379716
Secondary identifying numbers	N/A

Submission date: 05/12/2014
Registration date: 13/04/2015
Last edited: 14/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Lorraine Brennan
Scientific

UCD
Belfield
Dublin 4
D4
Ireland

ORCID ID	0000-0002-7711-7499

Study information

Study design	This is a randomised, crossover dietary intervention study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	Investigating the metabolic end products of casein-derived bioactive peptides
Study acronym	FHIGM
Study objectives	To identify metabolic end products after consumption of milk casein-derived bioactive peptides
Ethics approval(s)	Human Research Ethics Committee in University College Dublin (UCD), 17/10/14, ref: LS-14-34-Drummond-Brennan.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	05/12/2014
Completion date	31/12/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	10
Key inclusion criteria	Healthy male and females free-living Caucasians aged 18-65 years
Key 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
Date of first enrolment	01/01/2015
Date of final enrolment	01/01/2016

Locations

Countries of recruitment

Ireland

Study participating centre

UCD Institute of Food and Health

Dublin
Ireland

Sponsor information

Food for Health Ireland
University/education

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

"ROR"	https://ror.org/01nvbq395

Funders

Funder type

Research organisation

Food for Health (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	It is intended that the results of this study will be published in an academic journal.
IPD sharing plan