Search for Bovine miRNA Transference to Humans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03740087|
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 15, 2018
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|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|
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
- 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
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
|Monterrey, Nuevo Leon, Mexico, 66455|
|Principal Investigator:||Fermín Mar-Aguilar, Dr.||Universidad Autonoma de Nuevo Leon|