Search for Bovine miRNA Transference to Humans
Search for the Transfer of Bovine miRNA to Humans by Comparing the Omnivore Group With a Vegan Group After a Dietary Intervention
1 other identifier
interventional
29
1 country
1
Brief Summary
Background: Foods derived from plants and animals contain miRNAs, and, some reports have detected diet-derived miRNAs circulating in mammalian serum. It is still unclear if the miRNAs present in food can be absorbed by the gastrointestinal tract and brought to the tissues to perform regulatory functions. The transfer of functional exogenous miRNA has been demonstrated in bacterial and viral infections but it is less well characterized in mammals. Edible bovine tissues contain unique profiles of human-homologous miRNAs that withstand cooking. If miRNAs from other species can cross the gastrointestinal barrier, it could have implications in gene regulation and health. Objective: Determine whether miRNAs from beef cross the gastrointestinal barrier and are transferred to human plasma. Methods: The investigators obtained fasting plasma from 29 healthy subjects divided in two groups: the omnivore group (6 men, 8 women) and the vegan group (8 men, 7 women; control group). Each participant was given a standard meal with or without beef depending on their group, then the plasma was collected at 2, 4 and 6 hours after the meal. The changes in the levels of of miR-1, miR-10b, miR-22, miR-92 and miR-192 were analysed by quantitative Polymerase Chain Reaction (qPCR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2016
CompletedFirst Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedNovember 15, 2018
November 1, 2018
7 months
November 6, 2018
November 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative amount of miR-1, miR-10b, miR-22, miR-92 and miR-192 in plasma
Quantification of miR-1, miR-10b, miR-22, miR-92 and miR-192 in plasma after meal time
Change from Baseline microRNA levels at 2, 4 and 6 hours after intervention
Study Arms (2)
Omnivorous diet
EXPERIMENTALThis group was assigned a meal containing beef (test meal) that consisted of 200 g roast beef with salad (lettuce, tomato, lentils) and a cup of rice.
Vegan diet
ACTIVE COMPARATORThis group was assigned a control meal consisted of salad (lettuce, tomato, lentils) and a cup of rice.
Interventions
Determine if the transfer of bovine miRNAs is carried out after a meal containing beef.
Eligibility Criteria
You may qualify if:
- For omnivorous subjects was that they should consume beef at least three times per week.
- For vegan subjects was that they should have followed a strict vegan diet for at least one year
You may not qualify if:
- For all subjects included pregnancy, menstruation during study sample collection, use of medicine or food supplements, intestinal malabsorption and intolerance to ingredients included in the diet intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cristina Rodriguez-Padilla
Monterrey, Nuevo León, 66455, Mexico
Related Publications (18)
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Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fermín Mar-Aguilar, Dr.
Universidad Autonoma de Nuevo Leon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 14, 2018
Study Start
April 13, 2015
Primary Completion
November 16, 2015
Study Completion
May 22, 2016
Last Updated
November 15, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share