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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 286419 0
Australian Egg Corporation
Suite 4.02, Level 4
107 Mount Street
North Sydney NSW 2060
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
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
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
T2DM is the fastest growing chronic illness in Australia, with over 3.2 million people estimated to have diabetes and pre-diabetes, and a further 275 individuals being diagnosed with diabetes every day. As diabetes is the 6th leading cause of death in Australia, interventions to manage this condition and its complications should be a priority for Australian society.
Despite many theoretical advantages of eggs in T2DM, there is a general paucity of good quality prospective data on the effects of high egg consumption in this group. There has only been one short duration clinical investigation in people with T2DM (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high –protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592). After 12 weeks, participants with T2DM on a high cholesterol, reduced energy diet (2 eggs/day) lost the same amount of weight and had similar improvements in lipids, blood pressure and glycaemic control as those on an isoenergetic low cholesterol diet. The major limitations of this study were its short duration (12 weeks), the null finding in the primary outcome for which the study was powered (10% difference in the change in LDL-C between groups), and participants being prescribed a reduced energy diet which could be a confounding factor.
Eggs contain a number of important nutrients that may reduce the risk of cardiovascular disease including folate, long chain omega 3 fatty acids, and arginine (a precursor for nitric oxide). They have also been shown to improve HDL-C (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high–protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592; Mutungi G, Ratliff, J, Puglisi, M et al. Dietary cholesterol from eggs increases plasma HDL cholesterol in overweight men consuming a carbohydrate-restricted diet. J Nutr 2008; 138: 272-276). Improvements in HDL-C are known to reduce cardiovascular risk (Barter P, Gotto AM, LaRosa JC et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events, N Engl J Med 2007; 357: 1301-1310). Eggs are a nutrient-dense food, yet are not high in energy. Despite being rich in cholesterol, the amount of total fat and saturated fat in eggs is not high and the fat in eggs is predominantly unsaturated (44% monounsaturated; 11% polyunsaturated).
In addition to potential beneficial effects of eggs on circulating lipid levels, higher protein eating patterns may have benefits for weight loss by inducing increased satiety and enhancing metabolic rate and lipid metabolism. Thus eggs are unlikely to be detrimental to people with T2DM and may be beneficial. Despite this, there is a negative perception toward egg consumption in people with diabetes. This notion largely results from world-wide press releases that have followed the publication of a number of epidemiological studies indicating that a high egg consumption, though not associated with adverse cardiovascular outcomes in the general population, may be associated with worse outcomes in people with T2DM (Hu FB, Stampfer MJ, Rimm EB et al. A prospective study of egg consumption and risk of cardiovascular disease in men and women, JAMA 1999; 281: 1387-94; Djousse L & Gaziano JM. Egg consumption in relation to cardiovascular disease and mortality: the Physicians’ Health Study. Am J Clin Nutr 2008; 87: 964-9). While epidemiological studies may provide insight into possible associations, they do not show causal relationships and findings are often affected by many confounding, and often hidden, factors. For example, at the time that these studies were being conducted, a public health campaign was advising people to limit their cholesterol intake, including their consumption of eggs. Therefore, individuals that were consuming > 7 eggs per week at this time may have been less likely to follow healthy dietary and lifestyle advice in general. It would be impossible to control for these factors from the available data. Furthermore the theoretical increase in cardiac risk from the cholesterol contained in eggs is likely to be minimal when compared to other cardiovascular risk factors including saturated fat intake, lack of physical activity, smoking, hypertension and obesity.
To address the limitations of previously conducted research, this prospective, randomised controlled study will include both an active intervention (initial 3 month weight maintenance period followed by a 3 month weight loss period) and follow-up period (6 months) to determine the potential health benefits of a high egg diet in pre-diabetes and those with T2DM. Both groups will be stratified during the randomisation process according to medication usage. The palatability and acceptability of both the diets will be examined throughout the 12 month study.
Trial website
http://sydney.edu.au/medicine/research/units/boden/index.php
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
tania.markovic@sydney.edu.au
Contact person for public queries
Name 18253 0
Dr 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
nick.fuller@sydney.edu.au
Contact person for scientific queries
Name 9181 0
Dr 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
nick.fuller@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary