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Search for Bovine miRNA Transference to Humans

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ClinicalTrials.gov Identifier: NCT03740087
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Cristina Rodriguez-Padilla, Universidad Autonoma de Nuevo Leon

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).


Condition or disease Intervention/treatment Phase
Vegan Diet Other: Omnivorous diet Other: Vegan diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Baseline blood samples were obtained after 12 hours overnight fast; the postprandial miRNA state was measured after intake of a meal with beef (test meal) that consisted of 200 g roast beef with salad (lettuce, tomato, lentils) and a cup of rice. The control diet consisted of the same intervention, without the roast beef. Each intervention day the meals were prepared with fresh food. Participants ate meals under control of the study staff. Postprandial samples were collected at 2, 4 and 6 hours after the diet intervention. The subjects did not eat or drink again until the end of sample collection.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Search for the Transfer of Bovine miRNA to Humans by Comparing the Omnivore Group With a Vegan Group After a Dietary Intervention
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : November 16, 2015
Actual Study Completion Date : May 22, 2016

Arm Intervention/treatment
Experimental: Omnivorous diet
This 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.
Other: Omnivorous diet
Determine if the transfer of bovine miRNAs is carried out after a meal containing beef.

Active Comparator: Vegan diet
This group was assigned a control meal consisted of salad (lettuce, tomato, lentils) and a cup of rice.
Other: Vegan diet
Used as a baseline for miRNA levels in blood




Primary Outcome Measures :
  1. Relative amount of miR-1, miR-10b, miR-22, miR-92 and miR-192 in plasma [ Time Frame: Change from Baseline microRNA levels at 2, 4 and 6 hours after intervention ]
    Quantification of miR-1, miR-10b, miR-22, miR-92 and miR-192 in plasma after meal time



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740087


Locations
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Mexico
Cristina Rodriguez-Padilla
Monterrey, Nuevo Leon, Mexico, 66455
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Fermín Mar-Aguilar, Dr. Universidad Autonoma de Nuevo Leon

Additional Information:
Publications:

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Responsible Party: Cristina Rodriguez-Padilla, Principal Investigator, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03740087     History of Changes
Other Study ID Numbers: Bovine miRNA assay FCB
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina Rodriguez-Padilla, Universidad Autonoma de Nuevo Leon:
miRNA
Xenomirs
Diet
Vegan