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:
Nutrigenomic effect of the consumption of beef in the lipid metabolism of adults clinically healthy from the northeast of Mexico
Acronym of Scientific Title:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
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.
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
Telephone:
+52-8999243627 ext. 87723
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:
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
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.
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
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:
Center for Genomic Biotechnology - National Polytechnic Institute
Postal Address:
Boulevard del Maestro sin número, Colonia 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 sin número, Colonia 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 :
Avenue Guillermo Ruiz Massieu Helguera # 239 La Escalera, Mexico City, CP 07320. Mexico
Correo electrónico:
anunezv@ipn.mx
nvangela@yahoo.com.mx
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 considered an excellent source of high-quality protein and micronutrients. The high saturated fatty acid (SFA) composition of beef has been associated with cardiovascular diseases; however, this is a controversial issue because at present, no evidence has scientifically proven such an association. Wagyu cattle have been used as an option to generate high-quality fatty acids (FAs) in beef and have been crossed with local beef cattle (Wagyu-Cross). In Mexico, Wagyu-Cross is marketed assuming the same quality as purebred Wagyu meat without scientific support. This study aimed to determine whether the differences in the FA composition of Wagyu-Cross and commercial beef affected lipid metabolism in frequent consumers of beef. The study is a randomized, controlled, double-blinded phase IV clinical trial. Thirty-four volunteers completed treatments in which 120 g ground beef was consumed 3 days per week for 2 weeks. Volunteers were randomized to the "A" (commercial meat) or "B" (Wagyu-Cross meat) groups. The beef fat content was 87% higher, the SFA content was 2.3% lower, and the monounsaturated fatty acid (MUFA) C18:1 n-9 concentrations were higher in Wagyu-Cross beef than in commercial beef. The B group exhibited a significantly larger change from baseline in the serum lipid profile in total cholesterol (TC) (-4.7% versus +6.9%), low-density lipoprotein (LDL) (-4.1% versus +10.0%), nonhigh-density lipoprotein (non-HDL) (-6.1% versus +4.9%), and the ratio of three atherogenic indexes-TC/HDL (-3.5% versus +6.4%), LDL/HDL (-2.8% versus +14.6%), and non-HDL/HDL (-4.7% versus +9.3%)-than the A group. This result confirms that meat FA composition is a key point for redirecting cattle breeding strategies and promotes beef as a healthful protein source. PRACTICAL APPLICATION: Here, we found new evidence based on a clinical trial that beef with a favorable fatty acid composition (i.e., monounsaturated fatty acid and polyunsaturated fatty acid content) is a key factor in improving parameters associated with consumer health. This information will support the design of cattle breeding strategies as an option to promote beef consumption as a healthier protein source and create opportunities for the development of the functional food industry.
Url for Results File:
https://ift.onlinelibrary.wiley.com/doi/epdf/10.1111/1750-3841.15739
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:
