Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001266853
Ethics application status
Approved
Date submitted
3/12/2012
Date registered
4/12/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Are eggs good for people with type 2 diabetes?
Scientific title
A 12 month randomised controlled trial to determine whether a high egg versus low egg diet will lead to improved lipid levels in people with type 2 diabetes.
Secondary ID [1] 281611 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 287895 0
Condition category
Condition code
Diet and Nutrition 288273 288273 0 0
Obesity
Metabolic and Endocrine 288276 288276 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A high egg diet of greater than or equal to 2 eggs/ day on 6 days per week. Each diet will be part of a lifestyle program providing individualised eating, activity and behavioural change therapy by a dietitian in one-on-one sessions. The initial three months will be focused on weight maintenance whereby participants are educated on healthier food choices but advised to maintain their weight. This will be followed by a 3-month weight loss intervention, from 3-6 months. Patient visits will take place every month for the initial 6 months. Sessions will be 1 hour duration. The weight loss diet will be hypo-caloric with a 500 kilocalorie deficit based on the Harris Benedict Equation for estimating energy requirements. All participants will be followed up from months 6 to 12 (i.e. they will come to the clinic for assessments at months 6, 9 and 12). The intervention group will be encouraged to consume the high egg diet for 12 months duration.
Intervention code [1] 286146 0
Treatment: Other
Intervention code [2] 286151 0
Lifestyle
Intervention code [3] 286152 0
Behaviour
Comparator / control treatment
A low egg diet of less than 2 eggs per week. This group will receive the same lifestyle program as the high egg diet group.
Control group
Active

Outcomes
Primary outcome [1] 288448 0
To determine whether a high egg diet will lead to improved lipid levels (higher high density lipoprotein cholesterol, HDL-C) in people with pre or type 2 diabetes mellitus (T2DM). If so, then this research will help to dispel the notion that eggs are bad for people with T2DM. Bloods will be collected every 3 months and measured by serum assay.
Timepoint [1] 288448 0
12 months
Secondary outcome [1] 300178 0
To determine whether a high egg diet will lead to improved glycaemic control in people with pre or T2DM. Bloods will be collected every 3 months and measured by serum assay.
Timepoint [1] 300178 0
12 months
Secondary outcome [2] 300179 0
To compare the palatability and acceptability of a high egg diet (greater than or equal to 2 eggs/day on 6 days per week) vs low egg diet (less than 2 eggs/week) in people with pre or T2DM. This will be assessed by a Food Acceptability Questionnaire provided every 3 months.
Timepoint [2] 300179 0
12 months
Secondary outcome [3] 300180 0
To determine whether better weight and appetite control are achieved in people on a high egg vs low egg energy restricted diet. Body weight measures and a visual analogue scale will be assessed every 3 months.
Timepoint [3] 300180 0
12 months
Secondary outcome [4] 300181 0
To examine the difference in total body fat mass and fat free mass between the two groups, before and after energy restriction. A bioelectrical impedance analysis will be measured every 3 months.
Timepoint [4] 300181 0
12 months
Secondary outcome [5] 300182 0
To determine whether people with high mindfulness scores at the beginning of the trial do better overall. The Five-Facet Mindfulness Questionnaire will be administered every 3 months.
Timepoint [5] 300182 0
12 months
Secondary outcome [6] 300183 0
To determine the cost effectiveness of a high egg vs low egg diet for the management of pre or T2DM. The healthcare system perspective will be adopted for the analysis and the Impact of Weight on Quality of Life Questionnaire will be administered to measures changes in quality of life.
Timepoint [6] 300183 0
12 months

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Pre-diabetes or type 2 diabetes (based on bloods taken within 6 months of screening).
To be eligible for the pre-diabetes criteria (based on “ADA. Standards of Medical Care in Diabetes-2012. Diabetes Care 35, supp 1. January 2012”), participants must have:
*a fasting plasma glucose greater than or equal to 5.6 mmol/L AND/OR
*2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 7.8 mmol/L AND/OR
*HbA1c greater than or equal to 5.7%
3. BMI greater than or equal to '25 kg/m^2'
The criteria for the diagnosis of type 2 diabetes will also be based on “ADA. Standards of Medical Care in Diabetes-2012. Diabetes Care 35, supp 1. January 2012”.
Participants must have:
*a fasting plasma glucose greater than or equal to 7.0 mmol/L AND/OR
*2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 11.1 mmol/L AND/OR
*HbA1c greater than or equal to 6.5% AND/OR
*When classic symptoms of hyperglycemia or hyperglycaemic crisis, a random plasma glucose greater than or equal to 11.1 mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with type 2 diabetes and a HbA1c > 9.0%
2. Vegetarian eating practices whereby eggs are avoided
3. Known egg allergies
4. Unstable angina or recent onset of cardiovascular disease (within 1 month of screening)
5. Participants with prior gastric surgery or gastric banding
6. A history of significant liver, kidney or gastrointestinal disease
7. Untreated thyroid disease
8. Alcohol or illicit drug abuse
9. Pregnant, breastfeeding, or planning pregnancy during the study
10. Use of weight loss medications and other drugs that affect body weight eg anti-psychotics, anti-depressants, or corticosteroids
11. Participants who have commenced a new prescription medication within 3 months of screening or change in dose regimen of a prescription medication within 1 month of screening
12. Participants with a history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening are eligible]
13. Inability to read and write English
14. Participants who frequently change smoking habits or who have stopped smoking within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking program at the time of screening will be eligible to start the trial after 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once a participant is deemed eligible for randomisation, they will be allocated to a treatment group (high egg or low egg diet). Random group allocation will be performed by the study database upon entry of the participant’s details and determination of eligibility. It will not be possible to override this allocation. Both groups will be stratified during the randomisation process according to age, sex, cholesterol medication treatment, and diabetes status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised block design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients are randomised to 1 of 2 dietary interventions (high egg or low egg diet).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2013
Actual
2/01/2013
Date of last participant enrolment
Anticipated
Actual
28/06/2013
Date of last data collection
Anticipated
Actual
10/07/2014
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 286419 0
Commercial sector/Industry
Name [1] 286419 0
Australian Egg Corporation
Country [1] 286419 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Egg Corporation
Address
Australian Egg Corporation
Suite 4.02, Level 4
107 Mount Street
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 285204 0
University
Name [1] 285204 0
University of Sydney
Address [1] 285204 0
The Boden Institute
University of Sydney
92-94 Parramatta Road,
Camperdown, NSW 2050
Country [1] 285204 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288498 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 288498 0
Ethics committee country [1] 288498 0
Australia
Date submitted for ethics approval [1] 288498 0
Approval date [1] 288498 0
15/10/2012
Ethics approval number [1] 288498 0
15321

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35006 0
A/Prof Tania Markovic
Address 35006 0
The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006
Country 35006 0
Australia
Phone 35006 0
+61286277365
Fax 35006 0
Email 35006 0
[email protected]
Contact person for public queries
Name 18253 0
Nick Fuller
Address 18253 0
The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006
Country 18253 0
Australia
Phone 18253 0
+61286271932
Fax 18253 0
Email 18253 0
[email protected]
Contact person for scientific queries
Name 9181 0
Nick Fuller
Address 9181 0
The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006
Country 9181 0
Australia
Phone 9181 0
+61286271932
Fax 9181 0
Email 9181 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a high-egg diet on cardiovascular risk factors in people with type 2 diabetes: The Diabetes and Egg (DIABEGG) study- A 3-mo randomized controlled trial.2015https://dx.doi.org/10.3945/ajcn.114.096925
EmbaseExamining mindfulness as a predictor of weight loss - Findings from the DIABEGG study.2017https://dx.doi.org/10.1016/j.orcp.2016.03.004
EmbaseEffect of a high-egg diet on cardiometabolic risk factors in people with type 2 diabetes: The Diabetes and Egg (DIABEGG) Study - Randomized weight-loss and follow-up phase.2018https://dx.doi.org/10.1093/ajcn/nqy048
N.B. These documents automatically identified may not have been verified by the study sponsor.