The effects of consuming melted cheese and grass-fed cheese on markers of metabolic health
| ISRCTN | ISRCTN11913510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11913510 |
| Secondary identifying numbers | LS-19-78-Gibney |
- Submission date
- 19/02/2021
- Registration date
- 16/03/2021
- Last edited
- 18/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Research suggests that foods with the same nutrient composition but eaten in different forms may have different effects on digestion and absorption. This concept, known as the food matrix, suggests that the predicted health effects of single nutrients may be different to the actual health effects when consumed as a whole food. Dairy foods are of particular interest. Recent studies have demonstrated a beneficial effect of dairy fat when eaten in the form of solid cheddar cheese on markers of metabolic health and cardiovascular disease risk. However, there is a need to examine whether melting cheese can affect these health benefits. In addition, evidence shows that cows fed primarily on pasture (grass) produce milk with higher nutrient concentrations compared to milk produced from grain-fed cows, namely CLA and n-3 fatty acids. Therefore, the aim of this study is to firstly, examine the effect of cheese form (solid or melted) on blood lipid profiles and other aspects of metabolic health, and secondly, to examine the effects of grass-fed vs grain-fed cheese on the same, as well as circulating levels of vitamins/fatty acids in a population of people aged 50-69. This type of research will help us understand more about how dairy fats are processed in the body and may help to inform food intake guidelines in the future.
Who can participate?
Healthy volunteers aged 50 and over with a BMI over 25 kg/m²
What does the study involve?
Participants will be randomly allocated to eat one of four test foods daily for a period of 6 weeks. Test food 1 is 120 g of solid, full fat, grass-fed cheddar cheese. Test food 2 is 120 g of melted, full fat, grass-fed cheddar cheese. Test food 3 consists of 49 g of butter, 30 g of calcium caseinate powder (protein powder) and a calcium supplement (control). Test food 4 is 120 g of solid, full fat, grain-fed cheddar cheese. Blood lipids, glucose and inflammatory markers will be measured from fasted blood samples collected at the start of the study and after the 6-week intervention period. Optional faecal samples will also be taken at the start and the end of the study to look at the differences in faecal composition and the microbiome.
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?
July 2019 to September 2023
Who is funding the study?
Enterprise Ireland (Ireland)
Who is the main contact?
Prof Eileen Gibney
eileen.gibney@ucd.ie
Contact information
Scientific
UCD Institute of Food and Health
UCD Centre for Molecular Innovation
Science Centre South
University College Dublin
Belfield
Dublin
D04 V1 W8
Ireland
 ORCID ID |
0000-0001-9465-052X |
|---|---|
| Phone | +353 (0)1 7162819 |
| eileen.gibney@ucd.ie |
Study information
| Study design | Single-centre randomized parallel intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | https://www.ucd.ie/foodandhealth/t4media/DAIRY%20FOODS%20STUDY%20PARTICIPANT%20INFORMATION%20SHEET%20%C3%A2%C2%80%C2%93%20cheese_grass_printable.pdf |
| Scientific title | A randomized control trial to investigate the impact of long-term consumption of melted cheddar, and to examine the effect of grass-fed vs total mixed ration (TMR) cheddar, on markers of metabolic health |
| Study objectives | 1. The form of the cheese matrix (solid or melted) has no impact on markers of metabolic health and there will be no difference in LDL-cholesterol or other markers of heart health between solid and melted cheese. 2. Dairy fat, eaten in the form of melted cheese, will have a different effect on blood lipids compared with the same constituents eaten in a different matrix (control). 3. Consumption of grass-fed cheese will have different outcomes on blood lipids and other markers of health compared to TMR-fed cheese consumption. |
| Ethics approval(s) | Approved 12/11/2019, Human Research Ethics Committee (UCD Office of Research Ethics, Roebuck Castle, University College Dublin, Belfield, Dublin 4; + 353 (0)1 716 8767; research.ethics@ucd.ie), ref: LS-19-78-Gibney |
| Health condition(s) or problem(s) studied | Blood lipids |
| Intervention | In this parallel, multi-arm study examining the effect of the intervention over 6 weeks, participants will consume one of the following diet treatments per day; 1. 120 g solid cheddar (non-melted), 100% pasture-fed cheddar 2. 120 g melted, 100% pasture-fed cheddar (test) 3. ‘Deconstructed cheese’ (49 g butter, 30 g calcium caseinate powder and a calcium supplement) (control) 4. 120 g solid 100% TMR cheddar (non-melted) For each block, n=80 participants will be recruited and randomly assigned to the study arm. However, the inclusion of interim analysis will test the effect of each treatment group compared to the control throughout the study period. This will be conducted after every 80 participants complete the intervention. If the interim analysis demonstrates sufficient statistical power at any stage, the total sample size may not be required. Due to the nature of the meals, the arms cannot be masked. |
| Intervention type | Behavioural |
| Primary outcome measure | Blood lipids measured with the HORIBA Pentra C400 from fasted blood samples collected at baseline and after the 6-week intervention period |
| Secondary outcome measures | Blood glucose and inflammatory markers measured with the HORIBA Pentra C400 from fasted blood samples collected at baseline and after the 6-week intervention period |
| Overall study start date | 01/07/2019 |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 320 (this is dependent on interim analysis previously described) |
| Key inclusion criteria | Current participant inclusion criteria as of 18/05/2022: 1. Healthy, not taking medication for cholesterol, blood pressure or digestion 2. Not following a prescribed diet for any reason (weight loss, cholesterol etc) 3. Free from dairy intolerance/allergy and consume an omnivorous diet 4. Male or female, aged ≥50 years 5. BMI >25 kg/m² Previous participant inclusion criteria: 1. Healthy, not taking medication for cholesterol, blood pressure or digestion 2. Not following a prescribed diet for any reason (weight loss, cholesterol etc) 3. Free from dairy intolerance/allergy and consume an omnivorous diet 4. Male or female, aged between 50– 69 years 5. BMI >25 kg/m² |
| Key exclusion criteria | Current participant exclusion criteria as of 18/05/2022: 1. Taking medication for cholesterol, blood pressure, or digestion 2. Following a prescribed diet for any reason (weight loss, cholesterol, etc) 3. Dairy intolerance/allergy and consuming an omnivorous diet 4. Male or female, aged <50 years 5. BMI <25 kg/m² Previous participant exclusion criteria: Immunocompromised and aged >70 years to be excluded as a COVID-19 precaution |
| Date of first enrolment | 16/01/2020 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Science Centre South
Belfield
Dublin
D04 V1W8
Ireland
Science Centre South
Belfield
Dublin
D04 V1W8
Ireland
Sponsor information
Research organisation
UCD Centre for Molecular Innovation and Drug Discovery
Science Centre South
Belfield
Dublin
D04 V1 W8
Ireland
| Phone | +353 (0)1 716 2391 |
|---|---|
| info@fhi.ie | |
| Website | https://www.fhi.ie/ |
Funders
Funder type
Government
Government organisation / National government
- Location
- Ireland
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| 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 high-impact peer reviewed journals such as the American Journal of Clinical Nutrition, British Journal of Nutrition, European Journal of Clinical Nutrition, Nutrients, Journal of Lipid Nutrition. At the moment, the study protocols and statistical analysis plan will not be made available. |
| 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
18/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/05/2022 to 31/08/2022.
2. The participant inclusion criteria have been updated.
3. The participant exclusion criteria have been updated.
4. The plain English summary has been updated to reflect the changes above.
26/02/2021: Trial's existence confirmed by the UCD Human Research Ethics Committee.
