Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001057976
Ethics application status
Approved
Date submitted
14/09/2020
Date registered
16/10/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
16/10/2020
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Eggs Over Easy: Effects of egg consumption on blood vitamin D levels in young adults.
Scientific title
Effects of egg consumption on the vitamin D status of young adults.
Secondary ID [1] 301353 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Eggs OVER Easy study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 317572 0
Condition category
Condition code
Diet and Nutrition 315659 315659 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a 12-week, three-arm, randomised controlled trial (RCT) in which young adults aged 25-40 years at risk of low vitamin D status will be randomly allocated (evenly 1:1:1) to: 1) 12 eggs per week; 2) 7 eggs per week or 3) a control group (2 eggs per week).

Participants will be supplied with the required number of fresh eggs every 3 weeks (delivered either to their home or to a convenient pick-up point) and will be asked to consume them in any way they prefer each week. Recipe suggestions and meal ideas will be provided.

Compliance with egg consumption will be measured using an 'egg consumption record' where participants will be asked to document the eggs they consume each day/week.
Intervention code [1] 317648 0
Prevention
Comparator / control treatment
The 2 eggs per week group is considered the comparator control group as we do not expect this dose to have any effect on vitamin D levels. This is to also ensure that they receive the same level of attention as the 7 and 12 egg per week group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 323895 0
Serum vitamin D [25-hydroxyvitamin D] levels.
Timepoint [1] 323895 0
Baseline & 12 weeks
Secondary outcome [1] 383225 0
Blood lipids (total cholesterol, HDL and LDL-cholesterol and triglycerides)
Timepoint [1] 383225 0
Baseline & 12 weeks
Secondary outcome [2] 383226 0
Adherence to egg consumption as measured by completed egg consumption records.
Timepoint [2] 383226 0
Questionnaire completely by participants weekly.
Secondary outcome [3] 383227 0
Acceptability to consuming eggs measured using the Food Acceptability Questionnaire.
Timepoint [3] 383227 0
Week 6 & 12 weeks

Eligibility
Key inclusion criteria
- Aged 25 to 40 years
- At risk of low vitamin D status based on a questionnaire asking about time spent outdoors, use of supplements, recent vacation in a sunny location or use of tanning facilities
- Willing to be randomly allocated to one of three groups that will be asked to consume either 2, 7 or 12 eggs per week for 12 weeks.
Minimum age
25 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Allergy/sensitivity to eggs
- Current smoker
- Regular consumer of whole eggs (>4/week on average over the past 3 months).
- Currently participating in a weight loss or dietary based program (or other research study), unless weight has been stable for >3 months.
- Diagnosed by doctor with any of the following: current cancer, diabetes, kidney disease, CVD or gastrointestinal disorders that can affect nutrient absorption.
- Taking any of the following medication that can affect vitamin D metabolism: Corticosteroids, Glucocorticoids, Thiazide diuretics, and Anticonvulsants.
- Consumption of 2 standard drinks of alcohol on more than 5 days per week over the past 2 weeks.
- Occupation and/or current lifestyle (in the last 3 months) that involves spending most of the day (at least 3 hours between 10 and 2pm) outdoors.
- Currently taking vitamin D supplements, vitamin D plus calcium supplements or multivitamin D supplements containing vitamin D (>200 IU/day)
- Holiday in a sunny location (such as Queensland) for longer than a week in the past 3 months.
- Use of tanning facilities at least twice in the past 3 months.
- Unable to commit to the study requirements

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be carried out. Allocation will be performed using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use simple randomisation using a computer-generated sequence (Microsoft Excel) to assign participants to the 3 study groups. Randomisation will be performed by an individual external to the study team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample size calculations were based on the expected difference for the change in serum 25(OH)D levels between the 12 eggs per week group (which is equivalent to approximately 2000 IU per week) and the 2 eggs per week control group, and the 7 eggs per week group (which is equivalent to 1150 IU per week) compared to the 2 eggs per week group. Our sample size calculations are based on the findings from Hayes et al. who reported that consumption of seven eggs per week (containing 3.5-4.5 µg per egg or 140-180 IU per egg) maintained serum 25(OH)D levels during winter compared to controls that experienced a mean 6.5 nmol/L [standard deviation (SD) = 6.7] decrease after 8 weeks. In a recent 16-week study in middle-aged women followed during the winter months in Melbourne we observed that serum 25(OH)D levels decreased by an average of 12 nmol/L after 4 months (Daly R et al. Am J Clin Nutr, 29 May, 2020). Based on the above findings, we estimate that a sample size of 51 participants (17 per group) will provide 90% power (two-tailed, P<0.05) to detect an 8 nmol/L difference between the 7 eggs per week group (who we hypothesize will experience no change in serum 25(OH)D) and the 2 eggs per week group (who we hypothesize will experience a mean 8 nmol/L reduction in serum 25(OH)D after 12 weeks), using a more conservative SD of 10. For the 12 eggs per week group, we expect to detect a mean 14 nmol/L difference relative to the 2 eggs per week group, due to a modest 6 nmol/L increase in the 12 eggs per week group and a mean 8 nmol/L reduction in the 2 eggs per week group (SD=10). These sample size calculations take into account a 20% attrition after 12 weeks.

All statistical analysis will be conducted using SPSS or Stata Statistical Software. All data will be initially analysed using an intention-to-treat approach. Sensitivity analysis (per protocol) will also performed by only including participants with 80% adherence to consuming the eggs. Analysis of covariance (ANCOVA) will be used to test between-group intervention effects, adjusting for the baseline variable being tested and other potential covariates such as self-report sun exposure, with the Tukey’s test used for post-hoc analysis. Paired t-tests will be used to test for within group changes over time. Normality and homogeneity of variance of the residuals will be checked using quantile-quantile plots and scatterplots respectively, prior to analysis. For any missing data, no imputation will be performed. Significance will be set at P <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
1/03/2021
Date of last participant enrolment
Anticipated
14/05/2021
Actual
14/05/2021
Date of last data collection
Anticipated
13/08/2021
Actual
13/08/2021
Sample size
Target
51
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305793 0
Commercial sector/Industry
Name [1] 305793 0
Australian Eggs Ltd.
Country [1] 305793 0
Australia
Primary sponsor type
University
Name
Professor Robin Daly (Deakin University)
Address
Deakin University
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences.
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 306231 0
None
Name [1] 306231 0
Address [1] 306231 0
Country [1] 306231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306064 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 306064 0
Deakin University
Locked Bag 20000
Geelong, VIC 3220
Ethics committee country [1] 306064 0
Australia
Date submitted for ethics approval [1] 306064 0
20/05/2020
Approval date [1] 306064 0
31/07/2020
Ethics approval number [1] 306064 0

Summary
Brief summary
The aim of this 12-week study is to compare the effectiveness of consuming 2, 7 and 12 eggs per week during the winter-spring months on serum (blood) vitamin D levels in adults aged 25-40 years who are at risk of low vitamin D status. This design will determine whether there is a dose-response relationship between egg consumption and vitamin D levels, and to help assess if there is an optimal number of eggs required to maintain vitamin D status during the winter-spring months.

We hypothesize that there will be a linear dose-relationship between egg consumption and vitamin D levels, and that the consumption of 7 eggs per week (equivalent to a weekly vitamin D dose of approx. 1150 IU) will maintain vitamin D levels relative to the low egg group who will experience a wintertime decline, whereas consumption of 12 eggs per week (equivalent to a weekly vitamin D dose of approx. 2000 IU) will be effective to increase vitamin D levels after 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102570 0
Prof Robin Daly
Address 102570 0
Deakin University
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences.
221 Burwood Highway
Burwood VIC 3125
Country 102570 0
Australia
Phone 102570 0
+61 3 92446040
Fax 102570 0
Email 102570 0
[email protected]
Contact person for public queries
Name 102571 0
Dr Jenny Gianoudis
Address 102571 0
Deakin University
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences.
221 Burwood Highway
Burwood VIC 3125
Country 102571 0
Australia
Phone 102571 0
+61 3 92446243
Fax 102571 0
Email 102571 0
[email protected]
Contact person for scientific queries
Name 102572 0
Prof Robin Daly
Address 102572 0
Deakin University
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences.
221 Burwood Highway
Burwood VIC 3125
Country 102572 0
Australia
Phone 102572 0
+61 3 92446040
Fax 102572 0
Email 102572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval has not been sought from the Deakin University Ethics Committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8065Study protocol  [email protected]
8066Statistical analysis plan  [email protected]
8067Informed consent form  [email protected]
8068Clinical study report  [email protected]
8069Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Daly RM, De Ross B, Gianoudis J, Tan SY. Dose-Resp... [More Details] 379878-(Uploaded-17-01-2024-12-49-06)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.