Clinical trial NCT05267522: Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Official title: Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemias
Physical Inactivity
Diet, Healthy
Keywords: Cholesterol
Eggs
Saturated Fat
Low density lipoprotein cholesterol
lutein
physical activity
Lead sponsor: University of South Australia
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2022-03-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 5 weeks
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 10 weeks
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 15 weeks
Secondary outcomes:
measure: Blood lipid profiling
timeFrame: Baseline
measure: Blood lipid profiling
timeFrame: 5 weeks
measure: Blood lipid profiling
timeFrame: 10 weeks
measure: Blood lipid profiling
timeFrame: 15 weeks
measure: Fasting glucose
timeFrame: Baseline
measure: Fasting glucose
timeFrame: 5 weeks
measure: Fasting glucose
timeFrame: 10 weeks
measure: Fasting glucose
timeFrame: 15 weeks
measure: Physical activity levels
timeFrame: Baseline
measure: Physical activity levels
timeFrame: 5 weeks
measure: Physical activity levels
timeFrame: 10 weeks
measure: Physical activity levels
timeFrame: 15 weeks
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: 5 weeks
measure: Waist circumference
timeFrame: 10 weeks
measure: Waist circumference
timeFrame: 15 weeks
measure: Blood Pressure
timeFrame: Baseline
measure: Blood Pressure
timeFrame: 5 weeks
measure: Blood Pressure
timeFrame: 10 weeks
measure: Blood Pressure
timeFrame: 15 weeks
measure: Dietary saturated fat intake
timeFrame: Baseline
measure: Dietary saturated fat intake
timeFrame: 5 weeks
measure: Dietary saturated fat intake
timeFrame: 10 weeks
measure: Dietary saturated fat intake
timeFrame: 15 weeks
measure: Dietary cholesterol intake
timeFrame: Baseline
measure: Dietary cholesterol intake
timeFrame: 5 weeks
measure: Dietary cholesterol intake
timeFrame: 10 weeks
measure: Dietary cholesterol intake
timeFrame: 15 weeks
measure: Dietary Energy intake
timeFrame: Baseline
measure: Dietary Energy intake
timeFrame: 5 weeks
measure: Dietary Energy intake
timeFrame: 10 weeks
measure: Dietary Energy intake
timeFrame: 15 weeks
measure: Dietary Macronutrients
timeFrame: Baseline
measure: Dietary Macronutrients
timeFrame: 5 weeks
measure: Dietary Macronutrients
timeFrame: 10 weeks
measure: Dietary Macronutrients
timeFrame: 15 weeks
measure: Dietary Lutein+Zeaxanthin
timeFrame: Baseline
measure: Dietary Lutein+Zeaxanthin
timeFrame: 5 weeks
measure: Dietary Lutein+Zeaxanthin
timeFrame: 10 weeks
measure: Dietary Lutein+Zeaxanthin
timeFrame: 15 weeks
measure: Sleep
timeFrame: Baseline
measure: Sleep
timeFrame: 5 weeks
measure: Sleep
timeFrame: 10 weeks
measure: Sleep
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of South Australia Clinical Trial Facility
state: South Australia
Study officials:
affiliation: University of South Australia
name: Jonathan D Buckley, PhD
role: PRINCIPAL_INVESTIGATOR
References: