University of South Australia Clinical Trial Facility
Adelaide, South Australia, 5000, Australia
NCT Number: NCT05267522
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).
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Adelaide, South Australia, 5000, Australia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol
Other names: High cholesterol + low saturated fat diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol
Other names: Low cholesterol + high saturated fat diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol
Other names: Average Australian Diet
Time frame: Baseline
Plasma LDL-C levels (mmol/L)
Time frame: 5 weeks
Plasma LDL-C levels (mmol/L)
Time frame: 10 weeks
Plasma LDL-C levels (mmol/L)
Time frame: 15 weeks
Plasma LDL-C levels (mmol/L)
Time frame: Baseline
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time frame: 5 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time frame: 10 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time frame: 15 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time frame: Baseline
Plasma glucose levels (mmol/L)
Time frame: 5 weeks
Plasma glucose levels (mmol/L)
Time frame: 10 weeks
Plasma glucose levels (mmol/L)
Time frame: 15 weeks
Plasma glucose levels (mmol/L)
Time frame: Baseline
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time frame: 5 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time frame: 10 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time frame: 15 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time frame: Baseline
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time frame: 5 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time frame: 10 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time frame: 15 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time frame: Baseline
Seated blood pressure (mmHg)
Time frame: 5 weeks
Seated blood pressure (mmHg)
Time frame: 10 weeks
Seated blood pressure (mmHg)
Time frame: 15 weeks
Seated blood pressure (mmHg)
Time frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Time frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Time frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Time frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
Time frame: Baseline
Analysis of dietary intake based on food diaries
Time frame: 5 weeks
Analysis of dietary intake based on food diaries
Time frame: 10 weeks
Analysis of dietary intake based on food diaries
Time frame: 15 weeks
Analysis of dietary intake based on food diaries
Time frame: Baseline
Analysis of dietary intake based on food diaries
Time frame: 5 weeks
Analysis of dietary intake based on food diaries
Time frame: 10 weeks
Analysis of dietary intake based on food diaries
Time frame: 15 weeks
Analysis of dietary intake based on food diaries
Time frame: Baseline
Sleep patterns assessed using accelerometers
Time frame: 5 weeks
Sleep patterns assessed using accelerometers
Time frame: 10 weeks
Sleep patterns assessed using accelerometers
Time frame: 15 weeks
Sleep patterns assessed using accelerometers
University of South Australia
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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