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Are eggs good for people with type 2 diabetes?

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001266853
Enrollment
140
Registered
2012-12-04
Start date
2013-01-02
Completion date
2013-06-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pl

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.

Sponsors

Australian Egg Corporation
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 18, 2026