Revisiones para Effect of beef consumption on lipid metabolism | Registro Público Cubano de Ensayos Clínicos

--- 23 Agosto 2019 - 10:48am por Gladys
+++ 21 Octubre 2020 - 3:08pm por lazara
--05-20T04:00:00
+-05-20T00:00:00
-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
--07-20T04:00:00
+-07-20T00:00:00
--09-20T04:00:00
+-09-20T00:00:00
--09-20T04:00:00
+-09-20T00:00:00
-/08/23
+/10/21
-/08/23
+/10/21

Revisión de 21 Octubre 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

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

País:

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

País:

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

País:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627

Email :

asifuentes@ipn.mx

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

Correo electrónico:

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:

Click here

Ensayos Registrados

Proceso de Registro

Effect of beef consumption on lipid metabolism

Acerca del RPCEC

Recursos útiles