Effect of high and low calcium in a cheese matrix
| ISRCTN | ISRCTN11663659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11663659 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | LS-16-60-Feeney-Gibney |
| Sponsor | University College Dublin |
| Funder | Enterprise Ireland |
- Submission date
- 07/07/2022
- Registration date
- 12/07/2022
- Last edited
- 24/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The aim of this study is to further our understanding of the effect of the cheese matrix on blood lipid (fat) profiles. Previous studies have observed that cheddar cheese consumption can result in a lowering of low-density lipoprotein (LDL) cholesterol (“bad” cholesterol). This is thought to occur through the calcium in cheese binding to the fat, reducing intestinal absorption and increasing faecal excretion. This may be specific to the form of the calcium present within the matrix of cheese, but this is not confirmed since other studies have used a variety of dairy foods and their matrices are all different, so it is not possible to test the effect of calcium alone from these studies. This study aims to find out whether increasing the calcium in a cheese matrix will increase the faecal fat excreted compared with a reduced calcium cheese, and the reduced calcium cheese plus a supplement.
Who can participate?
Healthy male volunteers aged 18-35 years with no known metabolic disease and with a body mass index (BMI) in the normal range
What does the study involve?
Volunteers will be given all of their food and drinks for three 2-week periods. They will keep a diary of this and anything they eat additional to what is provided. They will come to the intervention suites at UCD for weight and height measures, and give a blood sample at baseline, before and after each dietary period. During the last 5 days of each 2-week period, they will collect all their stool produced throughout the day, and it will be collected by the researchers once a day (three collection periods in total).
What are the possible benefits and risks of participating?
There are no known risks or benefits of participating. There may be some discomfort at the site of venepuncture when giving blood samples.
Where is the study run from?
University College Dublin (Ireland)
When is the study starting and how long is it expected to run for?
March 2016 to May 2018
Who is funding the study?
Enterprise Ireland
Who is the main contact?
Emma Feeney, emma.feeney@ucd.ie
Contact information
Scientific
S2.16a Science Centre South
UCD Institute of Food and Health
Belfield
Dublin
Dublin 4
Ireland
 ORCID ID |
0000-0003-3234-6340 |
|---|---|
| Phone | +353 (0)17162247 |
| emma.feeney@ucd.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomised cross over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Effect of low-calcium and high-calcium cheddar cheese consumption on the excretion of faecal fat – a 2-week cross-over dietary intervention study |
| Study objectives | Consuming calcium within the matrix of cheese increases faecal fat excretion compared to the same amount of calcium eaten as cheese plus a supplement. |
| Ethics approval(s) | Approved 16/03/2016, UCD HREC (UCD Office of Research Ethics Roebuck Castle University College Dublin Belfield, Dublin 4, Ireland; +353 1 716 8767; no email provided), ref: LS-16-60-Feeney-Gibney |
| Health condition(s) or problem(s) studied | Effect of cheese calcium on fat excretion and blood lipids |
| Intervention | A randomisation table was used and participants were randomised into a sequence to complete 3 conditions: 1. High calcium cheddar cheese (240 g/day) for 2 weeks 2. Reduced calcium cheddar cheese (240 g/day) for 2 weeks 3. Reduced calcium cheddar cheese (240 g/day) for 2 weeks + calcium supplement It is not possible to blind participants due to the supplement. Volunteers will be given all of their food and drinks for three 2-week periods. They will keep a diary of this and anything they eat additional to what is provided. They will come to the intervention suites at UCD for weight and height measures, and give a blood sample at baseline, before and after each dietary period. During the last 5 days of each 2-week period, they will collect all their stool produced throughout the day, and it will be collected by the researchers once a day (three collection periods in total). |
| Intervention type | Other |
| Primary outcome measure(s) |
Faecal fat excretion rates (g/day) measured during the last 5 days of each period. |
| Key secondary outcome measure(s) |
1. Fasting levels of Total Cholesterol, HDL-Cholesterol and LDL-cholesterol (mmol/L), triglycerides (mmol/L), Non-Esterified Fatty Acid (NEFA) (mmol/L), C-reactive protein (ng/ ml) and glucose (mmol/L) measured at baseline, and post-intervention for each study condition. |
| Completion date | 24/05/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Male |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Healthy male volunteers 2. Aged 18-35 years 3. Normal range body mass index (BMI) 4. No known metabolic disease |
| Key exclusion criteria | 1. Female 2. Aged under 18 or over 35 years 3. BMI outside the normal range 4. Metabolic disease |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 05/03/2018 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Belfield
Dublin
D4
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Participant level data will not be available for sharing as per the data sharing statement in the ethics application |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/02/2023 | 24/02/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/02/2023: Publication reference added.
12/07/2022: Trial's existence confirmed by UCD Dublin.
