Condition category
Not Applicable
Date applied
01/02/2019
Date assigned
07/02/2019
Last edited
06/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent research has identified a new type of substance naturally found in foods that may play a role in nutrition and health. This substance is called microRNA and is naturally occurring in both plants and animals. microRNAs are thought be be involved in controlling the levels of substances produced by cells. Along with other foods, milk contains microRNAs within exosomes (bubbles released by cells). This study aimed to investigate whether people absorb immune-relevant microRNAs from cow’s milk into the blood and whether these affect human immune responses.

Who can participate?
Health adults who are not pregnant, smokers or intolerant to cow's milk.

What does the study involve?
Participants drank five different drinks based on 1 litre of cow's milk or soy-based infant formula with a period of at least a week between each one. Some of the drinks contained extra cow's milk exosomes and some had the exosomes destroyed. Blood samples were taken immediately before the drink and at 3, 6 and 9 hours afterwards.

What are the possible benefits and risks of participating?
There were no direct benefits to research participants. Minimal risks were anticipated for the participants. However, potential risks included intolerance to milk, fatigue due to blood draws, and risk of bruising. No other physical, psychological, financial, etc., risks were expected. Blood draws may make someone become anxious, light-headed, nauseous, or generally uneasy. All blood draws were performed by University of Nebraska-Lincoln Health Center phlebotomists (experts in taking blood samples) who have been trained and are experienced in dealing with subjects who may become anxious during blood draw procedures.

Where is the study run from?
University of Nebraska-Lincoln (USA)

When is the study starting and how long is it expected to run for?


Who is funding the study?
The Gerber Foundation (USA)

Who is the main contact?
Dr. Janos Zempleni, jzempleni2@unl.edu

Trial website

Contact information

Type

Public

Primary contact

Mr Ezra Mutai

ORCID ID

Contact details

Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316 Leverton Hall
Lincoln
68583
United States of America
+1 704-421-1477
emutai@huskers.unl.edu

Type

Scientific

Additional contact

Dr Janos Zempleni

ORCID ID

http://orcid.org/0000-0001-5492-4661

Contact details

Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316C Leverton Hall
Lincoln
NE 68583-0806
USA
Lincoln
68583
United States of America

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

13755

Study information

Scientific title

Bioavailability of immunomodulatory microRNAs from bovine milk exosomes and cytokine secretion by peripheral blood mononuclear cells ex vivo in humans

Acronym

Study hypothesis

Immune-related miRNAs in bovine milk exosomes are bioavailable and modulate immune responses in humans. Immunomodulatory microRNAs depend on co-stimulation with concanavalin A to elicit cytokine secretion by peripheral blood mononuclear cells ex vivo in humans

Ethics approval

Approved 10/10/2013, University of Nebraska-Lincoln Institutional Review Board (IRB) (301 Canfield, PO Box 880433, Lincoln, NE 68588-0433, USA; +1 (402) 472-3123; unlresearch@unl.edu), ref: 20131013755FB

Study design

Randomized crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Relevance of bovine milk exosomes as bioactive food compounds and use of exosomes for drug delivery.

Intervention

12 healthy adults received 5 different milk meals in a randomized cross-over design, with a washout period of at least 1 week between each meal. The milk meals were 1 l of 1% fat bovine milk, 1 l of 1% fat sonicated bovine milk (exosomes depleted), 1 l of soy infant formula, 1 l of soy infant formula fortified with bovine milk exosomes, and 1 l of 1% fat sonicated bovine milk and fortified with bovine milk exosomes (exosomes containing microRNAs depleted by ultrasonication and then exosomes isolated from 1 l of bovine milk added back to the sonicated milk). Blood samples were collected before and at timed intervals after consumption of the various milk meals for analysis of bioavailability of six immune-relevant microRNAs in plasma and secretion of cytokines by peripheral blood mononuclear cells ex vivo.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Levels of six immune-relevant microRNA found in bovine milk exosomes in plasma using real-time quantitative polymerase chain reaction (RT-qPCR) before (0 h) and at timed intervals (3, 6,and 9 h) after a milk meal

Secondary outcome measures

1. Secretion of inflammation-related cytokines by cultured human peripheral blood mononuclear cells (PBMCs) collected before and 6 h after milk consumption and stimulated with or without Concanavalin A (Con A) was assessed using a customized Milliplex Map Human Cytokine/Chemokine Magnetic Bead Panel Immunoassay
2. Secretion of cytokines by PBMCs treated ex vivo with microRNA-loaded exosomes assessed using a customized Milliplex Map Human Cytokine/Chemokine Magnetic Bead Panel Immunoassay

Overall trial start date

10/10/2013

Overall trial end date

06/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Healthy adults

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Pregnant women
2. Smokers
3. Persons with lactose and milk protein intolerance or gastrointestinal disorders

Recruitment start date

09/04/2015

Recruitment end date

30/11/2017

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Nebraska-Lincoln
Department of Nutrition and Health Sciences University of Nebraska-Lincoln 316C Leverton Hall Lincoln, NE 68583-0806
Lincoln
68583
United States of America

Sponsor information

Organisation

The Gerber Foundation

Sponsor details

4747 West 48th Street
Suite 153
Fremont
MI 49412-8119
Fremont
49412
United States of America
231-924-3175
tgf@gerberfoundation.org

Sponsor type

Other

Website

http://www.gerberfoundation.org/

Funders

Funder type

Charity

Funder name

Gerber Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/03/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes