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

NCT04832217 | Completed

• 1 other identifier: EFA 144/16
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Body Weight Changes; Habits, Diet; Habit, Food; Life Change Events

Keywords

randomized controlled crossover trial; young adults; Pyrenean beef

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (13)

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

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

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

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

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

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

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

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

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

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

Other Outcomes (1)

• Change from baseline in the body fat in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.

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

Study Arms (2)

Pyrenees' beef group

EXPERIMENTAL

In 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).

Other: Pyrenees´ Beef diet

Conventional Chicken group

NO INTERVENTION

In 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).

Interventions

Pyrenees´ Beef diet OTHER

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

Pyrenees' beef group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Genud Research Group

Zaragoza, 50001, Spain

Location

Related Publications (1)

• 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.

  PMID: 36145099 DERIVED

MeSH Terms

Conditions

Body Weight Changes; Feeding Behavior

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A cross-over randomized controlled study

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 5, 2021
• Study Start: January 20, 2019
• Primary Completion: June 28, 2019
• Study Completion: July 31, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)