The health implications of consuming processed meat deep-fried in extra virgin olive oil, with and without vegetables, within a cohort of cohabiting women
| ISRCTN | ISRCTN15421598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15421598 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CASVE-NM-21-525 |
| Sponsor | University of Valladolid |
| Funder | Scientific Foundation of Caja Rural de Soria |
- Submission date
- 09/08/2023
- Registration date
- 11/08/2023
- Last edited
- 01/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Dietary habits have been one of the most stable factors in all of human sociocultural heritage. Currently, we are witnessing a revolution because these habits are undergoing significant changes, resulting in a major impact on nutritional status. The trend of studying the influence of different foods on each other to achieve a diet rich in various nutrients while maintaining dietary culture in the field of health is important, especially for our elders. Few studies demonstrate that the proper consumption of meat with a balanced percentage of fat and lean, combined with vegetables, can result in greater fat removal through the food bolus. Fats consumed without accompanying high fibre content may have a higher absorption in the stomach. Therefore, using a processed and modified animal product with 50% lean and 50% fat can provide adequate nutrition without increasing absorption when taken with vegetables.
The overall aim of this study is to evaluate the health effects of the intake of processed meat deep fried in extra virgin olive oil combined with vegetables versus the same intake without vegetables.
Who can participate?
A community of cohabiting women with similar lifestyle habits in the city of Soria, Spain
What does the study involve?
Participants will be randomly assigned to the control and experimental groups. Both groups will consume 150 g of pork crackling deep-fried in EVOO twice a week; the experimental group will combine the intake with 200 g of vegetables while the control group will not. For all the participants, the rest of their regular diet will remain unchanged. Participants' measurements will be collected at baseline, before starting the dietary intervention, at 55 and 98 days into the intervention, and 34 days after the intervention ends.
What are the possible benefits and risks of participating?
The potential anticipated advantages include an improved lipid profile resulting from the increased intake of EVOO in the control group, and both EVOO and fibre in the experimental group. There are no risks associated with participation in the study.
Where is the study run from?
University of Valladolid (Spain)
When is the study starting and how long is it expected to run for?
May 2021 to December 2021
Who is funding the study?
Scientific Foundation of Caja Rural de Soria (Spain)
Who is the main contact?
Patricia Romero-Marco, patricia.romero@uva.es
Contact information
Scientific
C/ Universidad s/n
Soria
42005
Spain
 ORCID ID |
0000-0002-7020-7109 |
|---|---|
| Phone | +34 (0)637289401 |
| patricia.romero@uva.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of the consumption of processed meat and dietary fiber among older women |
| Study acronym | PROMEDIF |
| Study objectives | This study hypothesizes that the combined intake of processed meat and dietary fiber, as opposed to the sole consumption of processed meat, could influence fat absorption and, consequently, the lipid profile of the participants. This could lead to a reduction in total cholesterol levels in the combined consumption group compared to the sole processed meat consumption group. |
| Ethics approval(s) |
Approved 01/07/2021, Ethics Committee for Research with Medications (c/ Ramón y Cajal, 7, Valladolid, 47005, Spain; +34 (0)983 423077; jalvarezgo@saludcastillayleon.es), ref: CASVE-NM-21-525 |
| Health condition(s) or problem(s) studied | Consumption of processed meat and dietary fiber |
| Intervention | Randomized controlled clinical trial conducted within a community of women with similar lifestyle habits, where twice a week for a period of 98 days, one group (experimental) consumes 150 g of pork crackling along with 200 g of vegetables, and another group (control) consumes 150 g of pork crackling. Participants will be assigned a unique study identification number that will be randomly allocated (50% of participants in each group), without knowledge of the investigators collecting the samples or those analyzing them. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured fasting at baseline, 55, 98 and 132 days: |
| Key secondary outcome measure(s) |
Measured fasting at baseline, 55, 98 and 132 days: |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 42 |
| Total final enrolment | 41 |
| Key inclusion criteria | 1. Female gender 2. Homogeneous dietary habits 3. Very similar lifestyle habits 4. Signing the informed consent |
| Key exclusion criteria | 1. Diagnosed with dementia 2. Swallowing difficulty 3. Diagnosed with hypercholesterolemia |
| Date of first enrolment | 02/07/2021 |
| Date of final enrolment | 15/11/2021 |
Locations
Countries of recruitment
- Spain
Study participating centre
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Patricia Romero Marco (patricia.romero@uva.es). Informed consent was obtained from each and every participant, outlining the study's objectives, and procedures, as well as data anonymization and ethical and/or legal constraints. The data will be accessible from July 2022 to December 2025 upon request via email. Aggregate data pertaining to body composition, lipid profile, and biomarkers from any of the evaluation time points will be shared. Individual data will not be disclosed in any case. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/05/2025 | 01/09/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/09/2025: Publication reference added.
11/08/2023: Study's existence confirmed by the Ethics Committee for Research with Medications.
