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Effect of beef consumption on lipid metabolism
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23 August 2019 - 10:48am
by Gladys
21 October 2020 - 3:08pm
by lazara
Changes to
Status of evaluation date of Ethic Committee
-
2019-05-
20T04
:00:00
+
2019-05-
20T00
:00:00
Changes to
Postal address of Ethic Committee
-
Avenue Guillermo Ruiz Massieu Helguera # 239 La Escalera, Mexico City,
C.P:
07320
,
Mexico
+
Avenue Guillermo Ruiz Massieu Helguera # 239 La Escalera, Mexico City,
CP
07320
.
Mexico
Changes to
Study completion date
-
2020-07-
20T04
:00:00
+
2020-07-
20T00
:00:00
Changes to
Date of available results
-
2020-09-
20T04
:00:00
+
2020-09-
20T00
:00:00
Changes to
Date of first publication
-
2020-09-
20T04
:00:00
+
2020-09-
20T00
:00:00
Changes to
Record Verification Date
-
2019
/
08
/
23
+
2020
/
10
/
21
Changes to
Next update date
-
2020
/
08
/
23
+
2021
/
10
/
21
Revision of 21 October 2020 - 3:08pm:
Effect of beef consumption on lipid metabolism
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
NUTRIRES
Scientific title:
Nutrigenomic effect of the consumption of beef in the lipid metabolism of adults clinically healthy from the northeast of Mexico
Acronym of Scientific Title:
NUTRIRES
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center for Genomic Biotechnology - National Polytechnic Institute (IPN-Reynosa), Mexico
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
National Council of Science and Technology (Project number: 299055)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Ana
Midle name:
Maria
Last name:
Sifuentes-Rincon
Medical Specialty :
Biomedical researcher, specialist in Nutrigenomics and Animal Digestive Microbiotics
Affiliation:
Center for Genomic Biotechnology - National Polytechnic Institute
Postal address:
Boulevard del Maestro sin número, Colonia Narciso Mendoza
City:
Reynosa, Tamaulipas
Country:
Mexico
Zip Code:
88710
Telephone:
+52-8999243627
ext.
87723
Email address:
asifuentes@ipn.mx
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Mexico
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
23/09/2019
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Lipid metabolism
Health condition(s) code:
Lipid Metabolism
Healthy Volunteers
Intervention(s):
Group A (Experimental): 120 g of beef of specialized sale with a high content of monounsaturated fatty acids (race Wagyu-cross) three days a week for two weeks, prohibited consuming pork, fish or shellfish, followed by two weeks without food intervention. Group B (Control): 120 g of beef of habitual sale (commercial) with a high content of saturated fatty acids (mix of races Angus, Holstein, Charolais and Limousin) prohibited consuming pork, fish or shellfish, followed by two weeks without food intervention.
Intervention code:
Red Meat
Meat
Food
Diet, Food, and Nutrition
Food and Beverages
Fatty Acids
Fatty Acids, Monounsaturated
Intervention keyword:
Beef
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Cholesterol (value in mg/dL). Measurement time: at baseline (time 0) and 2 weeks Triglycerides (value in mg/dL). Measurement time: at baseline (time 0) and 2 weeks HDL-c (value in mg/dL). Measurement time: at baseline (time 0) and 2 weeks LDL-c (value in mg/dL). Measurement time: at baseline (time 0) and 2 weeks VLDL-C (value in mg/dL). Measurement time: at baseline (time 0) and 2 weeks Atherogenic index (Castelli index). Measurement time: at baseline (time 0) and 2 weeks
Key secondary outcomes:
Efficacy outcomes: 1. Measurements and anthropometric indexes. Measurement time: at baseline (time 0) and 2 weeks. It will measure by: -Body Max Index-BMI (Weight/(Height*Height). The weight expressed in Kg and, the height expressed in meters) -Waist circumference (Value expressed in cm). Measurement time: at baseline (time 0) and 2 weeks - Hip circumference (Value expressed in cm) - Waist-hip Index (Waist circumference/Hip circumference. All values are expressed in cm). 2. Glucose on an empty stomach (Value expressed in mg/dL). Measurement time: at baseline (time 0) and 2 weeks. 3. Biochemistry test (BUN, Urea, Creatinine, Uric acid, Total bilirubin, Direct bilirubin, Indirect bilirubin, TGO, TGP, LDH, Alkaline phosphatase, GGT, Total proteins, Albumin, Globulin, Albumin-globulin ratio, Calcium, Phosphorus, CPK, Sodium, Potassium, Chlorine (All are expressed as numerical values in the measurement units of the institution). Measurement time: at baseline (time 0) and 2 weeks
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
45 years
Inclusion criteria:
1. Patients older than 18 years 2. Aged between18 and 45 years 3. Body mass index (BMI) ≥ 17 kg/m2 and under 45 kg/m2 4. Eat beef 5. Signature written informed consent of the volunteer
Exclusion criteria:
1. Type 1 or type 2 diabetes 2. Hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥ 90 mmHg) 3. Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion 4. Alcoholism and/or drug dependence 5. Smoker (> 10 cigarettes a day) 6. Women who are pregnant or breastfeeding 7. Medicine consumption of or dietary supplements 8. The volunteer no longer wishes to be part of the study 9. Inability to comply with the instructions of the investigation
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Other
Other purpose:
Basic research
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Active
Study design:
Parallel
Phase:
4
Target sample size:
32
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Diana
Middle Name:
Alejandra
Last Name:
Vela-Vasquez
Specialty:
Human Nutrition
Affiliation:
Center for Genomic Biotechnology - National Polytechnic Institute
Postal Address:
Boulevard del Maestro sin número, Colonia Narciso Mendoza
City:
Reynosa, Tamaulipas
Country:
Mexico
Zip Code:
88710
Telephone:
+52-8999243627
Email :
dvelav@alumno.ipn.mx
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Ana
Middle Name:
Maria
Last Name:
Sifuentes-Rincon
Specialty:
Biomedical Researcher in Nutrigenomics and Animal Digestive Microbiotics
Affiliation:
Center for Genomic Biotechnology - National Polytechnic Institute
Postal Address:
Boulevard del Maestro sin número, Colonia Narciso Mendoza
City:
Reynosa, Tamaulipas
Country:
Mexico
Zip Code:
88710
Telephone:
+52-8999243627
Email :
asifuentes@ipn.mx
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Bioethics Committee of the National School of Medicine and Homeopathy
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
20/05/2019
Postal address of Ethic Committee :
Avenue Guillermo Ruiz Massieu Helguera # 239 La Escalera, Mexico City, CP 07320. Mexico
Telephone:
+52 5729-6000 ext. 55543
Email:
anunezv@ipn.mx
nvangela@yahoo.com.mx
About study completion
Section to complete the data related to the study completion.
Study completion date:
20/07/2020
Date of available results:
20/09/2020
Date of first publication:
20/09/2020
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000302
Date of Registration in Primary Registry:
23/08/2019
Record Verification Date:
2020/10/21
Next update date:
2021/10/21
Link to the spanish version:
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