Metabolic Syndrome X Clinical Trial
— EFCMRNAMSOfficial title:
Effect of Food Consumption on microRNA Related to Metabolic Syndrome. A Randomized Clinical Trial
Verified date | October 2016 |
Source | Universidad Juárez Autónoma de Tabasco |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Secretaria de Salud |
Study type | Interventional |
The objective of the Project is to assess the effect of traditional food on the expression of micro-ribonucleic acid (miRNA), which regulate genes related to glucose metabolism. It will be a randomized experimental research. The research hypothesis is that consumption of traditional food will resolve biomarkers of glucose-related anomalies. Students of The Academic Division of Health Sciences (DACS for its initials in Spanish) will be invited to participate and they will be divided randomly in two groups. The experimental group will receive daily, five days per week, during three months, a lunch based on traditional Mesoamerican food emphasizing local produce. The experimental group will be provided an equivalent ratio of fast food from the school cafeterias. In both groups, at the start and end of the protocol, values of lipid, glucose, reactive protein C, alanine aminotransferase, and glycosylated hemoglobin profiles will be determined through spectrophotometric methods. The levels of expression of five miARN involved in regulating genes related to glucose metabolism (miR-320, miR-33a/b, miR-145, miR-335, and miR-124a) will be determined also by means of PCR amplification techniques. Statistical analyses will be based on two-way ANOVA, with a Dunnet's test procedure to find significance in measurements; significance will be set at p ≤ 0.05.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | April 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 22 Years |
Eligibility |
Inclusion Criteria: - be student in DACS-UJAT - accept to eat traditional-food Exclusion Criteria: - those students being treated for diabetes mellitus - those students taking lipid-lowering drugs - those students pregnant - out of the 20- to 22-year-old range |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Universidad Juárez Autónoma de Tabasco |
Fonseca-Sanchéz MA, Pérez-Plasencia C, Fernández-Retana J, Arechaga-Ocampo E, Marchat LA, Rodríguez-Cuevas S, Bautista-Piña V, Arellano-Anaya ZE, Flores-Pérez A, Diaz-Chávez J, López-Camarillo C. microRNA-18b is upregulated in breast cancer and modulates genes involved in cell migration. Oncol Rep. 2013 Nov;30(5):2399-410. doi: 10.3892/or.2013.2691. — View Citation
Muñoz Cano JM, Aguilar AC, Hernández JC. Lipid-lowering effect of maize-based traditional Mexican food on a metabolic syndrome model in rats. Lipids Health Dis. 2013 Mar 15;12:35. doi: 10.1186/1476-511X-12-35. — View Citation
Muñoz Cano JM, Córdova Hernández J, Mayo H, Boldo León X. [Pre-diabetes and diabetes without association with overweight or obesity in Mexican youth]. Arch Latinoam Nutr. 2013 Jun;63(2):148-56. Spanish. — View Citation
Muñoz-Cano JM, Córdova-Hernández JA, del Valle-Leveaga D. [The healthy eating index of new students at an university of Mexico]. Nutr Hosp. 2015 Apr 1;31(4):1582-8. doi: 10.3305/nh.2015.31.4.8401. Spanish. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes on biochemical parameters and selected miRNA | The multiple measurements will be aggregate to evaluate the number of participants with abnormal laboratory values pre and post treatment and compare with control. Changes in the expression of microRNA selected. The hypothesis are with traditional-type food the biochemical parameters will be lesser than with cafeteria fast-food. Adverse events that can occur are hives, nausea and vomiting, abdominal distension, flatulence, diarrhea. It will be compared with the number of adverse events that occur in the control group. Traditional ethnic food is made with local products, especially vegetable. Although these are products that the population has consumed before, they can arise allergy from any product for which will be monitored after each meal. |
At end 12 week | Yes |
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