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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267522
• Other study ID #: 204327
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2022
• Source: University of South Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 31, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Healthy
• Hypercholesterolemia
• Hyperlipidemias
• Physical Inactivity

Intervention

Other:
• Egg diet
30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol
• Egg-free Diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol
• Control Diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol

Locations

Country	Name	City	State
Australia	University of South Australia Clinical Trial Facility	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
University of South Australia	American Egg Board

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density lipoprotein cholesterol (LDL-C)	Plasma LDL-C levels (mmol/L)	Baseline
Primary	Low-density lipoprotein cholesterol (LDL-C)	Plasma LDL-C levels (mmol/L)	5 weeks
Primary	Low-density lipoprotein cholesterol (LDL-C)	Plasma LDL-C levels (mmol/L)	10 weeks
Primary	Low-density lipoprotein cholesterol (LDL-C)	Plasma LDL-C levels (mmol/L)	15 weeks
Secondary	Blood lipid profiling	Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins	Baseline
Secondary	Blood lipid profiling	Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins	5 weeks
Secondary	Blood lipid profiling	Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins	10 weeks
Secondary	Blood lipid profiling	Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins	15 weeks
Secondary	Fasting glucose	Plasma glucose levels (mmol/L)	Baseline
Secondary	Fasting glucose	Plasma glucose levels (mmol/L)	5 weeks
Secondary	Fasting glucose	Plasma glucose levels (mmol/L)	10 weeks
Secondary	Fasting glucose	Plasma glucose levels (mmol/L)	15 weeks
Secondary	Physical activity levels	Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity	Baseline
Secondary	Physical activity levels	Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity	5 weeks
Secondary	Physical activity levels	Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity	10 weeks
Secondary	Physical activity levels	Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity	15 weeks
Secondary	Waist circumference	Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.	Baseline
Secondary	Waist circumference	Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.	5 weeks
Secondary	Waist circumference	Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.	10 weeks
Secondary	Waist circumference	Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.	15 weeks
Secondary	Blood Pressure	Seated blood pressure (mmHg)	Baseline
Secondary	Blood Pressure	Seated blood pressure (mmHg)	5 weeks
Secondary	Blood Pressure	Seated blood pressure (mmHg)	10 weeks
Secondary	Blood Pressure	Seated blood pressure (mmHg)	15 weeks
Secondary	Dietary saturated fat intake	Analysis of dietary intake based on 5-day food diaries	Baseline
Secondary	Dietary saturated fat intake	Analysis of dietary intake based on 5-day food diaries	5 weeks
Secondary	Dietary saturated fat intake	Analysis of dietary intake based on 5-day food diaries	10 weeks
Secondary	Dietary saturated fat intake	Analysis of dietary intake based on 5-day food diaries	15 weeks
Secondary	Dietary cholesterol intake	Analysis of dietary intake based on 5-day food diaries	Baseline
Secondary	Dietary cholesterol intake	Analysis of dietary intake based on 5-day food diaries	5 weeks
Secondary	Dietary cholesterol intake	Analysis of dietary intake based on 5-day food diaries	10 weeks
Secondary	Dietary cholesterol intake	Analysis of dietary intake based on 5-day food diaries	15 weeks
Secondary	Dietary Energy intake	Analysis of dietary intake based on 5-day food diaries	Baseline
Secondary	Dietary Energy intake	Analysis of dietary intake based on 5-day food diaries	5 weeks
Secondary	Dietary Energy intake	Analysis of dietary intake based on 5-day food diaries	10 weeks
Secondary	Dietary Energy intake	Analysis of dietary intake based on 5-day food diaries	15 weeks
Secondary	Dietary Macronutrients	Analysis of dietary intake based on food diaries	Baseline
Secondary	Dietary Macronutrients	Analysis of dietary intake based on food diaries	5 weeks
Secondary	Dietary Macronutrients	Analysis of dietary intake based on food diaries	10 weeks
Secondary	Dietary Macronutrients	Analysis of dietary intake based on food diaries	15 weeks
Secondary	Dietary Lutein+Zeaxanthin	Analysis of dietary intake based on food diaries	Baseline
Secondary	Dietary Lutein+Zeaxanthin	Analysis of dietary intake based on food diaries	5 weeks
Secondary	Dietary Lutein+Zeaxanthin	Analysis of dietary intake based on food diaries	10 weeks
Secondary	Dietary Lutein+Zeaxanthin	Analysis of dietary intake based on food diaries	15 weeks
Secondary	Sleep	Sleep patterns assessed using accelerometers	Baseline
Secondary	Sleep	Sleep patterns assessed using accelerometers	5 weeks
Secondary	Sleep	Sleep patterns assessed using accelerometers	10 weeks
Secondary	Sleep	Sleep patterns assessed using accelerometers	15 weeks