Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2018
Date assigned
16/02/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent studies show that foods of the same overall nutrient composition but eaten in different food structures result in different digestive effects, and subsequently different health effects. This is becoming known as the food matrix effect. Dairy foods are a particular example of this effect. A number of studies have shown that dairy fat eaten in the form of cheese has a lower cholesterol-increasing effect compared to the same fat eaten as butter, even when the other nutrients, such as protein and calcium, are controlled for. There are lots of theories about this, and evidence suggests that calcium and the type of protein may have an effect. Many of the studies are 6 weeks in length and look at the change in LDL cholesterol levels over time. However, LDL-cholesterol levels are just one factor for heart disease risk. Another factor is raised levels of circulating fatty acids after eating, known as post-prandial lipaemia. The aim of this study is to look at what happens in the hours after eating dairy fat in three different forms: as cheese, as a reduced fat cheese plus butter, and as butter, protein and calcium. It is thought that the cheese 'matrix' will result in lower circulating fatty acids compared to butter, and that the cheese and butter will give a result somewhere in between.

Who can participate?
Healthy volunteers

What does the study involve?
Participants eat three meals in a random order with a 5-7 day break in between meals. Meal 1 is 120g full fat cheddar cheese and a slice of low-fibre white toast. Meal 2 is 120g reduced fat cheddar cheese and a slice of low-fibre white toast. Meal 3 is 30g calcium caseinate powder. Circulating fatty acids and blood glucose are measured from blood samples collected at fasting, and hourly, on the hour, for the 6-hour period after eating.

What are the possible benefits and risks of participating?
There are no known benefits to participating. Potential risks are discomfort or bruising from the blood sampling, and the risk of finding the study food unpleasant.

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

When is the study starting and how long is it expected to run for?
February 2018 to August 2018

Who is funding the study?
Enterprise Ireland

Who is the main contact?
Dr Emma Feeney

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Feeney

ORCID ID

Contact details

UCD Centre for Molecular Innovation and Drug Discovery
Science Centre South
Belfield
Dublin
D04 V1 W8
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LS-17-103

Study information

Scientific title

Post-prandial randomised controlled trial to examine the postprandial effects of dairy fat within different matrices

Acronym

Study hypothesis

Dairy fat, when eaten in varying levels of a cheese matrix, will have different outcomes on postprandial lipids.

Ethics approval

Human Research Ethics Committee in University College Dublin, 24/01/2018, ref. LS-17-103

Study design

Single-centre randomised cross-over intervention trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Blood lipids

Intervention

Subjects will receive three meals which contain dairy fat in varying levels of a cheese matrix, with a slice of toast as a carrier, in a random order with a 5-7 day washout period in between meals. Due to the nature of the meals, the arms cannot be masked.

Arm 1: 120g full fat cheddar cheese and a slice of low-fibre white toast
Arm 2: 120g reduced fat cheddar cheese and a slice of low-fibre white toast
Arm 3: 30g calcium caseinate powder

Intervention type

Phase

Drug names

Primary outcome measure

Circulating fatty acids measured with a Randox Daytona from blood samples collected at fasting, and hourly, on the hour, for the 6-hour postprandial period

Secondary outcome measures

Blood glucose measured with a Randox Daytona from blood samples collected at fasting, and hourly for the 6-hour post-prandial period

Overall trial start date

01/02/2018

Overall trial end date

31/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Fasting triglycerides <2.5
2. BMI 18-35

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

8-10

Participant exclusion criteria

1. Familial hypercholesteraemia
2. Fasting triglycerides greater than 2.5
3. Any diagnosed metabolic disorder such as diabetes type 1 or 2

Recruitment start date

01/02/2018

Recruitment end date

31/05/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Science Centre South Belfield
Dublin
D04 V1 W8
Ireland

Trial participating centre

Food for Health Ireland
UCD Centre for Molecular Innovation and Drug Discovery Science Centre South, Belfield
Dublin
D04 V1 W8
Ireland

Sponsor information

Organisation

Food for Health Ireland

Sponsor details

UCD Centre for Molecular Innovation and Drug Discovery
Science Centre South
Belfield
Dublin
D04 V1 W8
Ireland
+ 353 (0)17162391
fhi@ucd.ie

Sponsor type

Not defined

Website

www.fhi.ie

Funders

Funder type

Government

Funder name

Enterprise Ireland

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Ireland

Results and Publications

Publication and dissemination plan

The results will be prepared for publication and submitted to relevant journals in the field. Other additional documents will not be made available at this time.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. The data will be stored on a password-protected computer (encrypted) as per UCD data protection recommendations.

Intention to publish date

31/08/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes