Plain English Summary
Background and study aims
Recent evidence has suggested the presence of extracellular vesicles (EVs) or exosome-like particles in food products such as milk and apple juice. These EVs contain miRNA as their cargo. miRNAs can silence gene expression by repression or degradation of mRNA. Hence, these foods containing miRNA in EVs may have important implications for human health. This study aims to investigate the presence of EVs in chicken eggs and whether egg consumption alters miRNA levels in human blood. The study also aims to highlight the potential of these EV-miRNA in influencing gene expression in humans.
Who can participate?
Healthy adults aged 24-36 years who are not pregnant or allergic to chicken eggs
What does the study involve?
Participants are randomly allocated to consume two, three or four eggs at three visits. There is a 1-week break between the visits. Blood and urine samples are collected before and after the consumption of eggs at different time intervals (i.e. 3, 4.5, 9, 12 and 24 hours).
What are the possible benefits and risks of participating?
There is no direct benefit to the participants. Blood sampling may cause anxiety in some participants. Therefore, experts who are trained and experienced in blood collection assist in sampling blood.
Where is the study run from?
University of Nebraska (USA)
When is the study starting and how long is it expected to run for?
October 2014 to October 2017
Who is funding the study?
1. National Institute of Food and Agriculture (NIFA) (USA)
2. National Institutes of Health (NIH) (USA)
3. Gerber Foundation (USA)
4. The Egg Nutrition Centre (USA)
5. University of Nebraska (USA)
Who is the main contact?
Dr Javaria Munir
jmunir2@unl.edu
Study website
Contact information
Type
Scientific
Contact name
Dr Javaria Munir
ORCID ID
http://orcid.org/0000-0002-5981-0329
Contact details
Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316 Leverton Hall
Lincoln
68583
United States of America
+1 (0)4022193670
jmunir2@unl.edu
Type
Scientific
Contact name
Prof Janos Zempleni
ORCID ID
http://orcid.org/0000-0001-5492-4661
Contact details
Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316 Leverton Hall
Lincoln
68583
United States of America
+1 (0)402 472 3270
jzempleni2@unl.edu
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Presence of extracellular vesicles and their miRNA cargo in chicken eggs and their potential to alter gene expression in non-avian species
Acronym
Study hypothesis
Chicken egg contains exosomal miRNA and egg consumption potentially modulates gene expression in humans.
Ethics approval(s)
Approved 06/10/2014, University of Nebraska Institutional Review Board, Lincoln (University of Nebraska-Lincoln, Office of Research and Economic Development, 2200 Vine Street, 275 Prem S. Paul Research Center at Whittier School, Lincoln, NE 68583-0863, USA; +1 (0)402 472 4491, +1 (0)402 472 8196; squinn@unl.edu, rwenzl2@unl.edu), ref: IRB 14585
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Other
Patient information sheet
Patient information sheets were collected as hard copies and are not available online.
Condition
Change in expression of miRNA/mRNA in humans after consumption of egg EVs
Intervention
In the first feeding study, five men and two women (ages 24-36 years) are randomly shuffled and assigned into groups: a group fed with two eggs, a group fed with three eggs and a group fed with four eggs. The second dose and third doses are administered using the same strategy as the first dose with a 1-week wash-out period between doses. Eggs are consumed as a single dose in 10 minutes. Participants are requested to not consume any poultry product before 24 hours. Blood is collected before egg consumption and after egg consumption (i.e. after 3, 4.5, 9, 12 and 24 hours). miRNA analysis is performed. Moreover, urine samples are collected before egg consumption and after every dose, followed by miRNA analysis.
In the second feeding study, five men (ages 26-35 years) are given a dose of four hard-boiled eggs. Blood plasma and peripheral blood mononuclear cells (PBMCs) are collected from the participants. miRNA analysis is performed from blood and PBMCs.
Intervention type
Other
Primary outcome measure
miRNA expression in blood plasma evaluated using quantitative real-time polymerase chain reaction (RT-qPCR) before and after consumption of hard-boiled eggs using 3, 4.5, 9, 12, 24 hours as timepoints
Secondary outcome measures
miRNA expression in peripheral blood mononuclear cells (PBMCs) evaluated using RT-qPCR before and after consumption of hard-boiled eggs using 3, 4.5, 9, 12, 24 hours as timepoints
Overall study start date
08/10/2013
Overall study end date
17/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy adults:
1. Ten men (aged 24-36 years)
2. Two women (aged 24-36 years)
Participant type(s)
Healthy volunteer
Age group
Adult
Sex
Both
Target number of participants
12
Total final enrolment
12
Participant exclusion criteria
1. Pregnant
2. Smoking
3. Allergic to eggs
Recruitment start date
06/10/2014
Recruitment end date
11/08/2016
Locations
Countries of recruitment
United States of America
Study participating centre
University of Nebraska-Lincoln
Department of Nutrition and Health Sciences
316C Leverton Hall
Lincoln
68583
United States of America
Sponsor information
Organisation
National Institute of Food and Agriculture
Sponsor details
805 Pennsylvania Avenue
Kansas City
64105
United States of America
+1 (0)202 401 4986
awards@nifa.usda.gov
Sponsor type
Government
Website
https://nifa.usda.gov/visit-nifa
ROR
Funders
Funder type
Government
Funder name
The Egg Nutrition Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute of Food and Agriculture
Alternative name(s)
USDA National Institute of Food and Agriculture, USDA's National Institute of Food and Agriculture, National Institute for Food and Agriculture of the United States Department of Agriculture, National Institute of Food and Agriculture at USDA, National Institute of Food and Agriculture (USDA), National Institute of Food & Agriculture, USDA/National Institute of Food and Agriculture, U.S. Department of Agriculture, National Institute of Food and Agriculture, NIFA, USDA - NIFA, USDA NIFA, NIFA USDA, USDA/NIFA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Funder name
National Institutes of Health
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Funder name
Gerber Foundation
Alternative name(s)
The Gerber Foundation, GerberFdnWMI
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United States of America
Funder name
University of Nebraska-Lincoln
Alternative name(s)
University of Nebraska, Lincoln, Universitas Nebraskensis, University of Nebraska, Nebraska, UNL, NU
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
United States of America
Results and Publications
Publication and dissemination plan
Publication in a high-impact factor journal in the field of nutrition.
Intention to publish date
30/07/2022
Individual participant data (IPD) sharing plan
No individual data will be shared; data will be reported in aggregated form. The participant-level data were collected as hard copies and stored in the designated space in the university. The study including all data analysis was completed in 2017 and the patients’ data were kept safely for 3 years after the completion of the study i.e. until 2020. After the specified period, the participant-level data were destroyed.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results of second feeding study | 14/04/2023 | 18/04/2023 | Yes | No |