Effect of Food Consumption on microRNA Related to Metabolic Syndrome

NCT02606812 | Unknown DMC

• 1 other identifier: UniversidadJAT
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Traditional-food

EXPERIMENTAL

During the 3 months, a dish containing traditional food will be provided 5 days per week. The food will contain an average of 600 Kcal, ≤ 50 mg of cholesterol, ≥ 10 g of fiber, ≥ 130 g of vegetables, and ≤ de 200 mg of sodium. Each dish will be accompanied with 3 standard-sized corn tortillas.

Dietary Supplement: Traditional-food

Control

NO INTERVENTION

Is the group who will intake the cafeteria fast food. The control group will receive habitually consumed fast food provided by the cafeteria of the campus at a similar caloric proportion.

Interventions

Traditional-food DIETARY_SUPPLEMENT

Intake of ethnic local food

Traditional-food

Eligibility Criteria

• Age: 20 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• be student in DACS-UJAT
• accept to eat traditional-food

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Juárez Autónoma de Tabasco: lead

Related Publications (4)

• Fonseca-Sanchez MA, Perez-Plasencia C, Fernandez-Retana J, Arechaga-Ocampo E, Marchat LA, Rodriguez-Cuevas S, Bautista-Pina V, Arellano-Anaya ZE, Flores-Perez A, Diaz-Chavez J, Lopez-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. Epub 2013 Aug 22.

  PMID: 23970382 BACKGROUND

• Munoz-Cano JM, Cordova-Hernandez 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.

  PMID: 25795944 RESULT

• Munoz Cano JM, Cordova Hernandez J, Mayo H, Boldo Leon X. [Pre-diabetes and diabetes without association with overweight or obesity in Mexican youth]. Arch Latinoam Nutr. 2013 Jun;63(2):148-56. Spanish.

  PMID: 24934071 RESULT

• Munoz Cano JM, Aguilar AC, Hernandez 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.

  PMID: 23497051 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. en C.

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 17, 2015
• Study Start: March 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 26, 2016

Record last verified: 2016-10