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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg Diet | Experimental | Egg diet, contains 2 eggs per day and limits saturated fat to 6% of energy intake. Cholesterol intake is 600mg/day. Protein and carbohydrate levels will be maintained at 20% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
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| Egg-free Diet | Active Comparator | Egg-free diet, limits cholesterol to 300 mg/day (no eggs) with saturated fat intake at 12% of energy intake. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
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| Control Diet | Active Comparator | Comparator diet based on the average Australian diet, limited to 1 egg per week, with saturated fat intake at 12% of energy intake. Cholesterol intake is 600 mg/day. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg diet | Other | 30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol |
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| Measure | Description | Time Frame |
|---|---|---|
| Low-density lipoprotein cholesterol (LDL-C) | Plasma LDL-C levels (mmol/L) | Baseline |
| Low-density lipoprotein cholesterol (LDL-C) | Plasma LDL-C levels (mmol/L) | 5 weeks |
| Low-density lipoprotein cholesterol (LDL-C) | Plasma LDL-C levels (mmol/L) | 10 weeks |
| Low-density lipoprotein cholesterol (LDL-C) | Plasma LDL-C levels (mmol/L) | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid profiling | Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins | Baseline |
| Blood lipid profiling | Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Buckley, PhD | University of South Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Australia Clinical Trial Facility | Adelaide | South Australia | 5000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40339906 | Derived | Carter S, Hill AM, Yandell C, Wood L, Coates AM, Buckley JD. Impact of dietary cholesterol from eggs and saturated fat on LDL cholesterol levels: a randomized cross-over study. Am J Clin Nutr. 2025 Jul;122(1):83-91. doi: 10.1016/j.ajcnut.2025.05.001. Epub 2025 May 6. | |
| 38272555 | Derived | Carter S, Hill AM, Yandell C, Buckley JD, Coates AM. Study protocol for a 15-week randomised controlled trial assessing the independent effects of high-cholesterol and high-saturated fat diets on LDL cholesterol. BMJ Open. 2024 Jan 25;14(1):e081664. doi: 10.1136/bmjopen-2023-081664. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Counter-balanced, cross-over trial with randomization to the starting diet will be via minimization, based on the LDL-C concentration at screening and sex. Minimization will ensure balanced LDL-C and sex between the treatment groups at commencement of each of the three diets.
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It will not be possible to blind participants to the diet being consumed, or the research dietician assisting the participants to comply with the diets. All other research staff involved in data collection will be blinded.
| Egg-free Diet | Other | 30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol |
|
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| Control Diet | Other | 30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol |
|
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| 5 weeks |
| Blood lipid profiling | Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins | 10 weeks |
| Blood lipid profiling | Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins | 15 weeks |
| Fasting glucose | Plasma glucose levels (mmol/L) | Baseline |
| Fasting glucose | Plasma glucose levels (mmol/L) | 5 weeks |
| Fasting glucose | Plasma glucose levels (mmol/L) | 10 weeks |
| Fasting glucose | Plasma glucose levels (mmol/L) | 15 weeks |
| Physical activity levels | Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity | Baseline |
| Physical activity levels | Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity | 5 weeks |
| Physical activity levels | Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity | 10 weeks |
| Physical activity levels | Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity | 15 weeks |
| Waist circumference | Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest. | Baseline |
| Waist circumference | Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest. | 5 weeks |
| Waist circumference | Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest. | 10 weeks |
| Waist circumference | Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest. | 15 weeks |
| Blood Pressure | Seated blood pressure (mmHg) | Baseline |
| Blood Pressure | Seated blood pressure (mmHg) | 5 weeks |
| Blood Pressure | Seated blood pressure (mmHg) | 10 weeks |
| Blood Pressure | Seated blood pressure (mmHg) | 15 weeks |
| Dietary saturated fat intake | Analysis of dietary intake based on 5-day food diaries | Baseline |
| Dietary saturated fat intake | Analysis of dietary intake based on 5-day food diaries | 5 weeks |
| Dietary saturated fat intake | Analysis of dietary intake based on 5-day food diaries | 10 weeks |
| Dietary saturated fat intake | Analysis of dietary intake based on 5-day food diaries | 15 weeks |
| Dietary cholesterol intake | Analysis of dietary intake based on 5-day food diaries | Baseline |
| Dietary cholesterol intake | Analysis of dietary intake based on 5-day food diaries | 5 weeks |
| Dietary cholesterol intake | Analysis of dietary intake based on 5-day food diaries | 10 weeks |
| Dietary cholesterol intake | Analysis of dietary intake based on 5-day food diaries | 15 weeks |
| Dietary Energy intake | Analysis of dietary intake based on 5-day food diaries | Baseline |
| Dietary Energy intake | Analysis of dietary intake based on 5-day food diaries | 5 weeks |
| Dietary Energy intake | Analysis of dietary intake based on 5-day food diaries | 10 weeks |
| Dietary Energy intake | Analysis of dietary intake based on 5-day food diaries | 15 weeks |
| Dietary Macronutrients | Analysis of dietary intake based on food diaries | Baseline |
| Dietary Macronutrients | Analysis of dietary intake based on food diaries | 5 weeks |
| Dietary Macronutrients | Analysis of dietary intake based on food diaries | 10 weeks |
| Dietary Macronutrients | Analysis of dietary intake based on food diaries | 15 weeks |
| Dietary Lutein+Zeaxanthin | Analysis of dietary intake based on food diaries | Baseline |
| Dietary Lutein+Zeaxanthin | Analysis of dietary intake based on food diaries | 5 weeks |
| Dietary Lutein+Zeaxanthin | Analysis of dietary intake based on food diaries | 10 weeks |
| Dietary Lutein+Zeaxanthin | Analysis of dietary intake based on food diaries | 15 weeks |
| Sleep | Sleep patterns assessed using accelerometers | Baseline |
| Sleep | Sleep patterns assessed using accelerometers | 5 weeks |
| Sleep | Sleep patterns assessed using accelerometers | 10 weeks |
| Sleep | Sleep patterns assessed using accelerometers | 15 weeks |
| D001519 | Behavior |