The potential influence of chicken egg consumption on humans
| ISRCTN | ISRCTN77867213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77867213 |
- Submission date
- 29/03/2022
- Registration date
- 15/04/2022
- Last edited
- 18/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316 Leverton Hall
Lincoln
68583
United States of America
 ORCID ID |
0000-0002-5981-0329 |
|---|---|
| Phone | +1 (0)4022193670 |
| jmunir2@unl.edu |
Scientific
Department of Nutrition and Health Sciences
University of Nebraska-Lincoln
316 Leverton Hall
Lincoln
68583
United States of America
| ORCID ID |
0000-0001-5492-4661 |
|---|---|
| Phone | +1 (0)402 472 3270 |
| jzempleni2@unl.edu |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Patient information sheets were collected as hard copies and are not available online. |
| Scientific title | Presence of extracellular vesicles and their miRNA cargo in chicken eggs and their potential to alter gene expression in non-avian species |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 17/10/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | Healthy adults: 1. Ten men (aged 24-36 years) 2. Two women (aged 24-36 years) |
| Key exclusion criteria | 1. Pregnant 2. Smoking 3. Allergic to eggs |
| Date of first enrolment | 06/10/2014 |
| Date of final enrolment | 11/08/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centre
316C Leverton Hall
Lincoln
68583
United States of America
Sponsor information
Government
805 Pennsylvania Avenue
Kansas City
64105
United States of America
| Phone | +1 (0)202 401 4986 |
|---|---|
| awards@nifa.usda.gov | |
| Website | https://nifa.usda.gov/visit-nifa |
"ROR" |
https://ror.org/05qx3fv49 |
Funders
Funder type
Government
No information available
Government organisation / National government
- 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, Cooperative State Research, Education, and Extension Service, NIFA, USDA - NIFA, USDA NIFA, NIFA USDA, USDA/NIFA, CSREES
- Location
- United States of America
Government organisation / National government
- Alternative name(s)
- Institutos Nacionales de la Salud, US National Institutes of Health, NIH
- Location
- United States of America
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Gerber Foundation, GerberFdnWMI, The Gerber Companies Foundation, GF
- Location
- United States of America
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Nebraska, Lincoln, University of Nebraska, Nebraska, Universitas Nebraskensis, UNL, NU
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication in a high-impact factor journal in the field of nutrition. |
| 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. |
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 |
Editorial Notes
18/04/2023: Publication reference added.
12/04/2022: Trial's existence confirmed by the University of Nebraska Institutional Review Board.
