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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

12 months

Secondary outcome [1]

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]

12 months

Secondary outcome [2]

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]

12 months

Secondary outcome [3]

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]

12 months

Secondary outcome [4]

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]

12 months

Secondary outcome [5]

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]

12 months

Secondary outcome [6]

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]

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?

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]

Commercial sector/Industry

Name [1]

Australian Egg Corporation

Address [1]

Australian Egg Corporation
Suite 4.02, Level 4
107 Mount Street
North Sydney NSW 2060

Country [1]

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]

University

Name [1]

University of Sydney

Address [1]

The Boden Institute
University of Sydney
92-94 Parramatta Road,
Camperdown, NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6 
Jane Foss Russell Building G02
University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/10/2012

Ethics approval number [1]

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

A/Prof Tania Markovic

Address

The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006

Country

Australia

Phone

+61286277365

Fax

tania.markovic@sydney.edu.au

Contact person for public queries

Name

Nick Fuller

Address

The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006

Country

Australia

Phone

+61286271932

Fax

nick.fuller@sydney.edu.au

Contact person for scientific queries

Name

Nick Fuller

Address

The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006

Country

Australia

Phone

+61286271932

Fax

nick.fuller@sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	The 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.	2015	https://dx.doi.org/10.3945/ajcn.114.096925
Embase	Examining mindfulness as a predictor of weight loss - Findings from the DIABEGG study.	2017	https://dx.doi.org/10.1016/j.orcp.2016.03.004
Embase	Effect 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.	2018	https://dx.doi.org/10.1093/ajcn/nqy048

N.B. These documents automatically identified may not have been verified by the study sponsor.

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