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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Hypercholesterolemia, Hyperlipidemias, Physical Inactivity, Diet, Healthy

Intervention / Treatment
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* Other: Egg diet
* Other: Egg-free Diet
* Other: Control Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 - 60 years Blood LDL-C <3.5 mmol/L (measured at screening using an automated analyser (Cholestech LDX System). Non-smoker (or other nicotine products) (minimum 6 months). Exclusion Criteria: Have diagnosed cardiovascular disease (including uncontrolled high blood pressure) or a chronic disease, including Type-1 or -2 diabetes, kidney or liver disease, gastrointestinal disorders requiring medical nutrition therapy (e.g., Crohn's disease, irritable bowel, coeliac disease) or any other condition that may have an impact on study outcomes. Have allergies or strong aversion to eggs or other components of the test foods (diets are not suitable for vegetarians). Consume more than 5 eggs per week in the month prior to beginning the trial. Participant has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week. Have changed medication or supplementation that might affect study outcomes in the last 3 months. Take vitamin, mineral, herbal supplementation, or medications that may have an impact on study outcomes. Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study. Are pregnant or breastfeeding. Show unwillingness to be randomized to either experimental group. Failure to satisfy the investigator regarding suitability to participate for any other reason. Are unwilling or unable to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg Diet<br>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. | Other: Egg diet<br>* 30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol<br>* Other names: High cholesterol + low saturated fat diet;|
| Active Comparator: Egg-free Diet<br>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. | Other: Egg-free Diet<br>* 30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol<br>* Other names: Low cholesterol + high saturated fat diet;|
| Active Comparator: Control Diet<br>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. | Other: Control Diet<br>* 30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol<br>* Other names: Average Australian Diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Eggs, Saturated Fat, Low density lipoprotein cholesterol, lutein, physical activity