Innovations Applied to the Pyrenean Beef Production to Enhance Consumer-identifiable Meat. (DIETAPYR2)
Primary Purpose
Body Weight Changes, Habits, Diet, Habit, Food
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pyrenees´ Beef diet
Sponsored by
About this trial
This is an interventional other trial for Body Weight Changes focused on measuring randomized controlled crossover trial, young adults, Pyrenean beef
Eligibility Criteria
Inclusion Criteria:
- To fill a medical history and informed consent to participate.
- Must be able to eat meat and chicken.
Exclusion Criteria:
- Diagnosticated of any chronic, metabolic, endocrine or nutrition related-disease.
- To be vegetarian or vegan
- To be under age (<18 years)
Sites / Locations
- Genud Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pyrenees' beef group
Conventional Chicken group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04832217
Brief Title
Innovations Applied to the Pyrenean Beef Production to Enhance Consumer-identifiable Meat.
Acronym
DIETAPYR2
Official Title
Innovaciones Aplicadas a la Cadena Productiva Pirenaica de Vacuno Para Valorizar Una Carne Identificable Por el Consumidor.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Habits, Diet, Habit, Food, Life Change Events
Keywords
randomized controlled crossover trial, young adults, Pyrenean beef
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A cross-over randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pyrenees' beef group
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional Chicken group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Pyrenees´ Beef diet
Intervention Description
24 participants were randomly assigned to a Pyrenees' beef diet, 3 serving per week during of 8 weeks.
Primary Outcome Measure Information:
Title
Changes in the triglycerides concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the HDL cholesterol in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the LDL cholesterol in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Secondary Outcome Measure Information:
Title
Changes in the iron concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the calcium concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the glucose concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the C-reactive protein in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the urea concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the zinc concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the creatinine concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the Palmitic Acid (C16) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the Stearic Acid (C18) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the Oleic Acid (C18_1n9) concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
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.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the Eicosapentadienoic Acid (C20_5n3) [EPA] concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Title
Changes in the Docosahexadienoic Acid (C22_6n3) [DHA] concentration in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
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).
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
Other Pre-specified Outcome Measures:
Title
Change from baseline in the body fat in those people who Pyrenean beef-based diet compared with the consumption of conventional chicken.
Description
Body fat percentage will be obtained by the same trained researcher and will be measured with an electronic scale (Tanita BC 418 MA, Tanita Europe GmbH, Sindelfingen, Germany). The participant stand on the platform of the scale without support, with the body weight evenly distributed between both feet. The participant will wear Light indoor clothing, excluding shoes, long trousers and sweater.
Time Frame
From the beginning of the study to the end of each period of study. 8 weeks per period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To fill a medical history and informed consent to participate.
Must be able to eat meat and chicken.
Exclusion Criteria:
Diagnosticated of any chronic, metabolic, endocrine or nutrition related-disease.
To be vegetarian or vegan
To be under age (<18 years)
Facility Information:
Facility Name
Genud Research Group
City
Zaragoza
ZIP/Postal Code
50001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36145099
Citation
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.
Results Reference
derived
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Innovations Applied to the Pyrenean Beef Production to Enhance Consumer-identifiable Meat.
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