None listed
Conditions
Brief summary
We propose to conduct a randomised controlled trial to compare the effect of eggs to a similar amount of protein and kilojoules from meat fish and chicken in the context of a high protein energy restricted dietary pattern. Primary outcome variables are LDL cholesterol and other cardiovascular risk factors. Our hypothesis is that daily consumption of 400mg dietary cholesterol as 2 eggs compared to an equivalent protein source low in saturated fat and low in cholesterol a kilojoule restricted diet will not adversely affect these outcomes We also propose to opportunistically compare the impact of these dietary patterns on post prandial glucose metabolism, cognitive function and satiety.
Interventions
12 week dietary intervention of daily high protein 31%/high dietary cholesterol 650mg/Fat 29%/Carbohydrate 37% diet for 3 meals per day. Both diets are energy restricted to achieve weight loss.
Sponsors
Commonwealth Scientific Research and Industraial Organisation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Body Mass Index (BMI) 25-40kg/m2 (this will be calculated for you)• Previously diagnosed Type 2 diabetes as noted on medical questionnaire or as assessed by a fasting blood glucose at screening (>6.1mmol/L).• HbA1C<9% (measured at screening)• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent.• No abnormality of clinical significance on medical history (i.e. life-threatening cancer, liver or metabolic disease or cardiovascular problems - unstable angina, previous incidence of myocardial infarction, stroke or heart irregularity).• Not have type 1 diabetes (self reported)• Be available for the duration of the study (12 weeks).
Exclusion criteria
Consumption of any over-the-counter medication or food (and unwilling to cease) that in the opinion of the investigator could interfere with the study (eg Policosanol, Metamucil, plant sterol margarines, psyllium).• The following items if taken need to be kept stable during the study: corticosteroids, diuretics, B-blockers, fish oil supplements, cholesterol lowering agents• History of heavy alcohol consumption (> 5 STD drinks/day)• Allergy to eggs• Type 2 diabetes controlled with insulin• Extended absences due to travel or other commitments• Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
Outcome results
None listed