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.
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:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
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.
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
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:
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
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:
Health condition(s) code:
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.
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.
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.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Randomized controlled trial
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
Affiliation:
Genomic Biotechnology Center – National Polytechnic Institute
Postal Address:
Boulevard del Maestro N/A, Suburb Narciso Mendoza
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.
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
Data Sharing Section to complete the data related to the data sharing plan.
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 date of Ethic Committee:
Postal address of Ethic Committee :
Guillermo Massieu Helguera #239 Fracc. “La Escalera” Ticoman ZC 07320, CDMX México
Telephone:
+52 55 57296000 Ext. 55512
About study completion Section to complete the data related to the study completion.
Results Study Section to complete the data related to the summarized results.
Summary study:
Beef is an excellent source of nutrients; unfortunately, most nutritional recommendations suggest limiting or even avoiding it. Studies have shown that the fatty acid composition of meat influences weight loss. This randomized controlled clinical trial evaluated the anthropometric and serum lipid changes after a food intervention that included frequent beef consumption (120 g consumed four days/week for four weeks). Volunteers were randomly assigned to the commercial or Wagyu-Cross beef groups, with the latter beef possessing higher fat and MUFA contents. Both groups exhibited reductions in body measurements and lipid profiles; however, the Wagyu-Cross group exhibited greater changes in weight (−3.75 vs. −2.90 kg) and BMI (−1.49 vs. −1.03) than the commercial group, without a significant difference between them. No significant group differences in lipid profiles were observed; however, the Wagyu-Cross group exhibited a more favorable change in decreasing the TC concentration (−7.00 mg/dL) and LDL-C concentration (−12.5 mg/dL). We suggest that high MUFA beef could be included in weight-loss programs since it does not affect weight loss and hasn’t a negative influence on lipid metabolism.
Url for Results File:
https://www.mdpi.com/2072-6643/14/18/3711
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
