NCT05267522

Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of South Australia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will comprise a randomized controlled, counter-balanced, cross-over trial to evaluate the independent effects of a high cholesterol (high egg), low saturated fat diet and a high saturated fat, low cholesterol diet on blood lipids. Evaluations also include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. The study will also investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).

Detailed description

Eggs are high in cholesterol but low in saturated fat. Data from cross-sectional, prospective, and randomized controlled trials (RCTs), suggest that egg intake does not adversely affect blood lipids or increase cardiovascular disease (CVD) risk. In fact, there is some evidence that egg consumption may reduce CVD risk. However, to date there has been no direct comparison of the effects of a high cholesterol (high egg), low saturated fat diet and a low cholesterol, high-saturated fat diet on blood lipids, and no studies have accounted for potential effects of differences in physical activity, which can also influence the blood lipid profile. Evaluations of the effect of egg consumption on blood lipids should include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. We will directly compare the effects of a high cholesterol, low saturated fat diet and a low cholesterol, high saturated fat diet on blood lipids, using egg consumption to manipulate dietary cholesterol intake, while also accounting for physical activity levels. The study will investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).

Conditions

• Hypercholesterolemia
• Hyperlipidemias
• Physical Inactivity
• Diet, Healthy

Interventions

Type	Name	Description
OTHER	Egg diet	30% fat \[6% saturated fat\], 20% protein, 40% carbohydrate, 600 mg cholesterol
OTHER	Egg-free Diet	30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 300 mg cholesterol
OTHER	Control Diet	30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 600 mg cholesterol

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-08-10
• Completion: 2023-08-31
• First posted: 2022-03-04
• Last updated: 2023-12-13

Locations

1 site across 1 country: Australia