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Trial from ANZCTR

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.

  • Recruitment status at the time of last update
    Completed
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 17/7/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12612001266853

Date registered

04 December 2012

Health condition

Type 2 diabetes

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Victoria

Recruitment status

Completed

Anticipated date of first participant enrolment

05 January 2013

Ethics application status

Approved

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.

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

0 No limit

Gender

Both males and females

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

Contact details and further information

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

Contact person for information and recruitment

Dr Nick Fuller
The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006
Australia
+61286271932
nick.fuller@sydney.edu.au