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Body Weight ChangesDIETAPYR2NCT04832217

Innovations Applied to the Pyrenean Beef Production to Enhance Consumer-identifiable Meat.

A study testing Pyrenees´ Beef diet in people with Body Weight Changes and Habits, Diet, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DIETAPYR2 study is a randomized controlled crossover trial consisting of two experimental periods each lasting 8 weeks. Enrolled participants were randomly assigned to either a Pyrenean beef-based diet or a conventional chicken-based diet and instructed to consume this meat three times a week. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Body Weight Changes, Habits, Diet, Habit, Food
What is being tested?
Pyrenees´ Beef diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
20 Jan 2019to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To fill a medical history and informed consent to participate.
  • Must be able to eat meat and chicken.

Who cannot join

  • Diagnosticated of any chronic, metabolic, endocrine or nutrition related-disease.
  • To be vegetarian or vegan
  • To be under age (<18 years)

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Genud Research Group

    Zaragoza, 50001

Other trials in Spain

About this study

Official title: Innovaciones Aplicadas a la Cadena Productiva Pirenaica de Vacuno Para Valorizar Una Carne Identificable Por el Consumidor.

The DIETAPYR2 study is a randomized controlled crossover trial consisting of two experimental periods each lasting 8 weeks. Enrolled participants were randomly assigned to either a Pyrenean beef-based diet or a conventional chicken-based diet and instructed to consume this meat three times a week.

In the first visit the medical history was obtained and anthropometric measurements, blood pressure (systolic and diastolic) and heart rate were taken. The day after the first visit, in the morning, a sample of blood, stool and urine was taken from the participants after an overnight fast. At the time of this visit (period 1), each participant was randomly assigned to a Pyrenean beef diet (intervention group) or a conventional chicken-based diet (control group).

After an experimental period of 8 weeks, the participants were invited to carry out the same evaluations as during the first visit. Subsequently, a 5-week washout period was carried out to eliminate the possible residual effects of the first experimental period. After the washout period, the participants were called back for the same assessments during a third visit just before the second experimental period (period 2). During this period, those who were previously on a Pyrenean beef diet (intervention group) were crossed with the conventional chicken diet (control group) and vice versa. Finally, after the second 8-week experimental period, the participants were retested as on previous visits.

Read the detailed description

The current study is a sub-study included in the DIETAPYR2 study (Innovations applied to the Pyrenean beef production to enhance consumer-identifiable meat), a randomized-controlled crossover trial consisting of two experimental periods with a duration of 8 weeks each. Enrolled participants were randomly assigned whether to a Pyrenean beef-based diet or to a Conventional chicken-based diet and were instructed to consume this meat three times per week. The Pyrenean beef is meat from young calves of native breeds, raised mainly on local pastures with a recognized impact in environmental and social sustainability of this rural geographical area. The Pyrenees (mountain range between France and Spain) is an optimal place for the practice of extensive livestock rearing given the richness of forages and the existence of native cow breeds that make use of these natural feedstuffs.

To ensure harmonization in the study, each chef of the 3 selected student accommodation halls was provided with instructions on the cooking methods for chicken and beef and they also received examples of recipes. Cooking methods were breaded, stewed and grilled for beef and breaded, stewed and roasted for chicken.

During the 2 weeks before the first period, researchers contacted with participants and obtained informed consent from them. Then, the first visit was scheduled where the medical history was obtained and the anthropometric measurements, blood pressure (systolic and diastolic) and heart rate measures were undertaken. The day after the first visit, in the morning, a blood, stool and urine sample was collected from participants after an overnight fast. At the time of this visit (period 1), each participant was randomly assigned to Pyrenees beef diet (intervention group) or a conventional chicken-based diet (control group).

Following an 8-week experimental period, participants were invited to perform the same assessments as during the first visit. Afterwards, a 5-week washout period took place to remove the possible residual effects of the first experimental period. Participants were requested not to change their diet or physical activity habits for the 5-week washout period. After the washout period, participants were called again to perform the same assessments during a 3rd visit right before the second experimental period (period 2). During this period those previously on Pyrenees beef diet (intervention group) were crossed to conventional chicken diet (control group) and vice versa. Finally, after the 8 week second experimental period, participants were assessed again as in previous visits.

Being tested
Pyrenees´ Beef diet
Keywords
randomized controlled crossover trial, young adults, Pyrenean beef
Medical subject headings
Body Weight Changes, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pyrenees´ Beef dietOther

    24 participants were randomly assigned to a Pyrenees' beef diet, 3 serving per week during of 8 weeks.

Study groups in NCT04832217
Study groupRoleWhat they receive
Pyrenees' beef groupExperimentalIn the first period, 24 participants were randomly assigned to a beef (Pyrenees' beef group). In the second period, 23 participants were randomly assigned to a beef (Pyrenees' beef group).
Receives: Other: Pyrenees´ Beef diet
Conventional Chicken groupNo interventionIn the first period, 23 participants were randomly assigned to a conventional chicken-based group (control group). In the second period, 24 participants were randomly assigned to a conventional chicken-based group (control group).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the triglycerides concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shipped to the laboratory. Standardized laboratory procedures use to analyse samples for triglycerides (mg/dL). Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  2. Changes in the HDL cholesterol in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shipped to the laboratory. Standardized laboratory procedures use to analyse samples for high density lipoprotein cholesterol (HDL). Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  3. Changes in the LDL cholesterol in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shipped to the laboratory. Standardized laboratory procedures use to analyse samples for low density lipoprotein cholesterol (LDL). Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

Secondary outcomes (13)
  1. Changes in the iron concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for iron concentration.

    Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  2. Changes in the calcium concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for calcium concentration.

    Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  3. Changes in the glucose concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for glucose concentration. Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  4. Changes in the C-reactive protein in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for C-reactive protein. Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  5. Changes in the urea concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for urea concentration. Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  6. Changes in the zinc concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for zinc concentration. Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  7. Changes in the creatinine concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for creatinine concentration. Also, the equip VITROS 5600 use to perform the hemogram.

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  8. Changes in the Palmitic Acid (C16) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Palmitic Acid (C16) concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  9. Changes in the Stearic Acid (C18) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Stearic Acid (C18) concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  10. Changes in the Oleic Acid (C18_1n9) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Oleic Acid (C18_1n9) concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  11. Changes in the Arachidonic Acid (C20_4n6) [AA_W6] concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Arachidonic Acid (C20_4n6) [AA_W6] concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  12. Changes in the Eicosapentadienoic Acid (C20_5n3) [EPA] concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Eicosapentadienoic Acid (C20_5n3) [EPA] concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

  13. Changes in the Docosahexadienoic Acid (C22_6n3) [DHA] concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

    Blood sample drew via venipuncture after 12h overnight fast. Sample will immediately shippe to the laboratory. Standardized laboratory procedures use to analyse samples for Docosahexadienoic Acid (C22_6n3) [DHA] concentration. Fatty acid will quantified after methylation by gas-liquid chromatography coupled to mass spectrometry detection (GS-MS).

    Measured: From the beginning of the study to the end of each period of study. 8 weeks per period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start20 Jan 2019
  3. Primary completion28 Jun 2019
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
A cross-over randomized controlled study
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832217
Sponsor's protocol ID
EFA 144/16
Acronym
DIETAPYR2
Status last verified
Apr 2021
First submitted
24 Mar 2021
Last updated
12 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rueda-De Torre I, Plaza-Diaz J, Miguel-Berges ML, Gil A, Grasa L, Esteban LM, Sabroso-Lasa S, Campo MM, Santolaria P, Moreno LA, Santaliestra-Pasias AM. Effect of the Consumption of Lean Red Meat from Beef (Pirenaica Breed) Versus Lean White Meat (Chicken) on the Gut Microbiota: A Randomized Cross-Over Study in Healthy Young Adults. Mol Nutr Food Res. 2025 Nov;69(21):e70189. doi: 10.1002/mnfr.70189. Epub 2025 Jul 25.

    PubMed 40711376
  • Santaliestra-Pasias AM, Miguel-Berges ML, Campo MM, Guerrero A, Olleta JL, Santolaria P, Moreno LA. Effect of the Intake of Lean Red-Meat from Beef-(Pirenaica Breed) versus Lean White-Meat on Body Composition, Fatty Acids Profile and Cardiovascular Risk Indicators: A Randomized Cross-Over Study in Healthy Young Adults. Nutrients. 2022 Sep 9;14(18):3724. doi: 10.3390/nu14183724.

    PubMed 36145099

Questions about this trial

What is this clinical trial studying?

A study testing Pyrenees´ Beef diet in people with Body Weight Changes and Habits, Diet, run by Universidad de Zaragoza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the triglycerides concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken. (time frame: From the beginning of the study to the end of each period of study. 8 weeks per period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04832217, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.

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