Revisions for NUTRIRES2 | Registro Público Cubano de Ensayos Clínicos

Comparing two revisions:

--- 15 July 2022 - 1:45pm by SSA
+++ 15 July 2022 - 1:45pm by SSA
 . Body mass index (BMI) ≥ 18.5 kg/m2 and less than 45 kg/m2.
 . Consume beef.
-. Sign volunteer's written informed consent
+. With a desire of lose weight and/or learn healthy eating habits.
+. Sign volunteer's written informed consent.

Current revision:

NUTRIRES2

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:

NUTRIRES2

Scientific title:

Effect of the consumption of beef with different composition of fatty acids, in the anthropometric measurements of volunteers under a personalized diet.

Acronym of Scientific Title:

NUTRIRES2

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

National Council for Science and Technology, project No. 294826 and 299055. National Polytechnic Institute SIP 20211323.

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 in Animal Digestive Nutrigenomics and Microbiomics

Affiliation:

Genomic Biotechnology Center – National Polytechnic Institute

Postal address:

Boulevard del Maestro N/A, Suburb Narciso Mendoza

City:

Reynosa

Country:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627

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:

16/05/2022

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:

Healthy

Health condition(s) code:

Healthy Volunteers

Intervention(s):

Group A (Experimental): 120 g of beef of specialized sale with a high content of monounsaturated fatty acids (breed Wagyu-cross) fourth days a week for fourth weeks, prohibited consuming pork, fish, shellfish, or any other type of beef. Group B (Control): 120 g of beef of habitual sale (commercial) with a high content of saturated fatty acids (mix of breeds Angus, Holstein, Charolais and Limousin) fourth days a week for fourth weeks, prohibited consuming pork, fish, shellfish, or any other type of beef.

Intervention code:

Red Meat

Meat

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):

Anthropometric measurements and indexs. Measurement time: At baseline, at 2 and 4 weeks. Weight (in Kg) Measurement time: At baseline, at 2 and 4 weeks. Waist circumference (in cm). Measurement time: At baseline, at 2 and 4 weeks Abdominal circumference (in cm). Measurement time: At baseline, at 2 and 4 weeks. Hip circumference (in cm). Measurement time: At baseline, at 2 and 4 weeks Waist-hip ratio (waist circumference/hip circumference in cm). Measurement time: At baseline, at 2 and 4 weeks Body Mass Index-BMI (Weight/(Height*Height). (Weight measured in Kg and height in m). Measurement time: At baseline, at 2 and 4 weeks

Key secondary outcomes:

Cholesterol, (value in mg/dL). Measurement time: at baseline (time 0), and at 4 weeks. Triglycerides, (value in mg/dL). Measurement time: at baseline (time 0), and at 4 weeks. HDL-c, (value in mg/dL). Measurement time: at baseline (time 0), and at 4 weeks. LDL-c, (value in mg/dL). Measurement time: at baseline (time 0), and at 4 weeks. VLDL-C, (value in mg/dL). Measurement time: at baseline (time 0), and at 4 weeks. Atherogenic index, measurement time: at baseline (time 0), and at 4 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:

25 years

Maximum age:

55 years

Inclusion criteria:

1. Age between 25 and 55 years. 2. Body mass index (BMI) ≥ 18.5 kg/m2 and less than 45 kg/m2. 3. Consume beef. 4. With a desire of lose weight and/or learn healthy eating habits. 5. Sign volunteer's written informed consent.

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:

Screening

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

28

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:

Genomic Biotechnology Center – National Polytechnic Institute

Postal Address:

Boulevard del Maestro N/A, Suburb Narciso Mendoza

City:

Reynosa

Country:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627

Email :

diana.w@outlook.com

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 N/A, Suburb Narciso Mendoza

City:

Reynosa

Country:

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:

14/09/2021

Postal address of Ethic Committee :

Guillermo Massieu Helguera #239 Fracc. “La Escalera” Ticoman ZC 07320, CDMX México

Telephone:

+52 55 57296000 Ext. 55512

Email:

nvangela@yahoo.com.mx

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/06/2022

Date of available results:

29/08/2022

Date of first publication:

29/08/2022

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:

RPCEC00000403

Date of Registration in Primary Registry:

31/03/2022

Record Verification Date:

2022/07/15

Next update date:

2023/07/15

Link to the spanish version:

Click here

Registered Trials

Registration process

NUTRIRES2

About the RPCEC

Useful resources