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
Secondary identifying numbers CASVE-NM-21-525
Submission date
09/08/2023
Registration date
11/08/2023
Last edited
11/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Patricia Romero-Marco
Scientific

C/ Universidad s/n
Soria
42005
Spain

ORCiD logoORCID ID 0000-0002-7020-7109
Phone +34 (0)637289401
Email patricia.romero@uva.es

Study information

Study designSingle-center randomized controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Laboratory, Medical and other records, Other
Study typeOther, Prevention, Quality of life, Efficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEffect of the consumption of processed meat and dietary fiber among older women
Study acronymPROMEDIF
Study objectivesThis 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) studiedConsumption of processed meat and dietary fiber
InterventionRandomized 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 typeBehavioural
Primary outcome measureMeasured fasting at baseline, 55, 98 and 132 days:
1. BMI measured using a bioimpedance analyzer and a talmeter. Waist circumference is measured using a non-stretch tape measure halfway between the last rib and the iliac crest to the nearest millimeter by a trained nutritionist.
2. Systolic and diastolic blood pressure collected with an OMRON BP7200 upper arm blood pressure monitor
3. Blood lipids measured are taken in fasting status from arterial blood by trained nurses
Secondary outcome measuresMeasured fasting at baseline, 55, 98 and 132 days:
1. Fat mass and fat-free mass measured using a bioimpedance analyzer
2. Heart rate measured with an OMRON BP7200 upper arm blood pressure monitor
Overall study start date02/05/2021
Completion date31/12/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexFemale
Target number of participants42
Total final enrolment41
Key inclusion criteria1. Female gender
2. Homogeneous dietary habits
3. Very similar lifestyle habits
4. Signing the informed consent
Key exclusion criteria1. Diagnosed with dementia
2. Swallowing difficulty
3. Diagnosed with hypercholesterolemia
Date of first enrolment02/07/2021
Date of final enrolment15/11/2021

Locations

Countries of recruitment

  • Spain

Study participating centre

Religious institution of the Clares in Soria
42002
Spain

Sponsor information

University of Valladolid
University/education

University Campus Duques de Soria
C/ Universidad, s/n
Valladolid
42004
Spain

Phone +34 (0)975 12 91 00
Email unidad.administrativa.soria@uva.es
Website http://www.uva.es/export/sites/uva/
ROR logo "ROR" https://ror.org/01fvbaw18

Funders

Funder type

Research organisation

Scientific Foundation of Caja Rural de Soria

No information available

Results and Publications

Intention to publish date30/09/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe 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.

Editorial Notes

11/08/2023: Study's existence confirmed by the Ethics Committee for Research with Medications.