Postprandial cheese matrix study
| ISRCTN | ISRCTN13406789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13406789 |
| Secondary identifying numbers | LS-17-103 |
- Submission date
- 08/02/2018
- Registration date
- 16/02/2018
- Last edited
- 08/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
UCD Centre for Molecular Innovation and Drug Discovery
Science Centre South, Belfield
Dublin
D04 V1 W8
Ireland
Study information
| Study design | Single-centre randomised cross-over intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Post-prandial randomised controlled trial to examine the postprandial effects of dairy fat within different matrices |
| Study hypothesis | Dairy fat, when eaten in varying levels of a cheese matrix, will have different outcomes on postprandial lipids. |
| Ethics approval(s) | Human Research Ethics Committee in University College Dublin, 24/01/2018, ref. LS-17-103 |
| 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 | Other |
| 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 study start date | 01/02/2018 |
| Overall study end date | 31/08/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8-10 |
| Participant inclusion criteria | 1. Fasting triglycerides <2.5 2. BMI 18-35 |
| 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
Study participating centres
Belfield
Dublin
D04 V1 W8
Ireland
Science Centre South, Belfield
Dublin
D04 V1 W8
Ireland
Sponsor information
Not defined
UCD Centre for Molecular Innovation and Drug Discovery
Science Centre South, Belfield
Dublin
D04 V1 W8
Ireland
| Phone | + 353 (0)17162391 |
|---|---|
| fhi@ucd.ie | |
| Website | www.fhi.ie |
"ROR" |
https://ror.org/01nvbq395 |
Funders
Funder type
Government
Government organisation / National government
- Location
- Ireland
Results and Publications
| Intention to publish date | 31/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Editorial Notes
08/08/2019: The intention to publish date has been changed from 31/08/2019 to 31/08/2020.
