Back to resultsIndependent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Primary Purpose
Hypercholesterolemia, Hyperlipidemias, Physical Inactivity
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Egg diet
Egg-free Diet
Control Diet
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring Cholesterol, Eggs, Saturated Fat, Low density lipoprotein cholesterol, lutein, physical activity
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.
Sites / Locations
- University of South Australia Clinical Trial FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Egg Diet
Egg-free Diet
Control Diet
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Secondary Outcome Measures
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Fasting glucose
Plasma glucose levels (mmol/L)
Fasting glucose
Plasma glucose levels (mmol/L)
Fasting glucose
Plasma glucose levels (mmol/L)
Fasting glucose
Plasma glucose levels (mmol/L)
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Blood Pressure
Seated blood pressure (mmHg)
Blood Pressure
Seated blood pressure (mmHg)
Blood Pressure
Seated blood pressure (mmHg)
Blood Pressure
Seated blood pressure (mmHg)
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Sleep
Sleep patterns assessed using accelerometers
Sleep
Sleep patterns assessed using accelerometers
Sleep
Sleep patterns assessed using accelerometers
Sleep
Sleep patterns assessed using accelerometers
Full Information
NCT ID
NCT05267522
First Posted
February 2, 2022
Last Updated
March 1, 2022
Sponsor
University of South Australia
Collaborators
American Egg Board
1. Study Identification
Unique Protocol Identification Number
NCT05267522
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Australia
Collaborators
American Egg Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemias, Physical Inactivity, Diet, Healthy
Keywords
Cholesterol, Eggs, Saturated Fat, Low density lipoprotein cholesterol, lutein, physical activity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Egg Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Egg-free Diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Egg diet
Other Intervention Name(s)
High cholesterol + low saturated fat diet
Intervention Description
30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol
Intervention Type
Other
Intervention Name(s)
Egg-free Diet
Other Intervention Name(s)
Low cholesterol + high saturated fat diet
Intervention Description
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol
Intervention Type
Other
Intervention Name(s)
Control Diet
Other Intervention Name(s)
Average Australian Diet
Intervention Description
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol
Primary Outcome Measure Information:
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Plasma LDL-C levels (mmol/L)
Time Frame
Baseline
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Plasma LDL-C levels (mmol/L)
Time Frame
5 weeks
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Plasma LDL-C levels (mmol/L)
Time Frame
10 weeks
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Plasma LDL-C levels (mmol/L)
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Blood lipid profiling
Description
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time Frame
Baseline
Title
Blood lipid profiling
Description
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time Frame
5 weeks
Title
Blood lipid profiling
Description
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time Frame
10 weeks
Title
Blood lipid profiling
Description
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Time Frame
15 weeks
Title
Fasting glucose
Description
Plasma glucose levels (mmol/L)
Time Frame
Baseline
Title
Fasting glucose
Description
Plasma glucose levels (mmol/L)
Time Frame
5 weeks
Title
Fasting glucose
Description
Plasma glucose levels (mmol/L)
Time Frame
10 weeks
Title
Fasting glucose
Description
Plasma glucose levels (mmol/L)
Time Frame
15 weeks
Title
Physical activity levels
Description
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time Frame
Baseline
Title
Physical activity levels
Description
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time Frame
5 weeks
Title
Physical activity levels
Description
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time Frame
10 weeks
Title
Physical activity levels
Description
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Time Frame
15 weeks
Title
Waist circumference
Description
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time Frame
Baseline
Title
Waist circumference
Description
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time Frame
5 weeks
Title
Waist circumference
Description
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time Frame
10 weeks
Title
Waist circumference
Description
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Time Frame
15 weeks
Title
Blood Pressure
Description
Seated blood pressure (mmHg)
Time Frame
Baseline
Title
Blood Pressure
Description
Seated blood pressure (mmHg)
Time Frame
5 weeks
Title
Blood Pressure
Description
Seated blood pressure (mmHg)
Time Frame
10 weeks
Title
Blood Pressure
Description
Seated blood pressure (mmHg)
Time Frame
15 weeks
Title
Dietary saturated fat intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
Baseline
Title
Dietary saturated fat intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
5 weeks
Title
Dietary saturated fat intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
10 weeks
Title
Dietary saturated fat intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
15 weeks
Title
Dietary cholesterol intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
Baseline
Title
Dietary cholesterol intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
5 weeks
Title
Dietary cholesterol intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
10 weeks
Title
Dietary cholesterol intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
15 weeks
Title
Dietary Energy intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
Baseline
Title
Dietary Energy intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
5 weeks
Title
Dietary Energy intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
10 weeks
Title
Dietary Energy intake
Description
Analysis of dietary intake based on 5-day food diaries
Time Frame
15 weeks
Title
Dietary Macronutrients
Description
Analysis of dietary intake based on food diaries
Time Frame
Baseline
Title
Dietary Macronutrients
Description
Analysis of dietary intake based on food diaries
Time Frame
5 weeks
Title
Dietary Macronutrients
Description
Analysis of dietary intake based on food diaries
Time Frame
10 weeks
Title
Dietary Macronutrients
Description
Analysis of dietary intake based on food diaries
Time Frame
15 weeks
Title
Dietary Lutein+Zeaxanthin
Description
Analysis of dietary intake based on food diaries
Time Frame
Baseline
Title
Dietary Lutein+Zeaxanthin
Description
Analysis of dietary intake based on food diaries
Time Frame
5 weeks
Title
Dietary Lutein+Zeaxanthin
Description
Analysis of dietary intake based on food diaries
Time Frame
10 weeks
Title
Dietary Lutein+Zeaxanthin
Description
Analysis of dietary intake based on food diaries
Time Frame
15 weeks
Title
Sleep
Description
Sleep patterns assessed using accelerometers
Time Frame
Baseline
Title
Sleep
Description
Sleep patterns assessed using accelerometers
Time Frame
5 weeks
Title
Sleep
Description
Sleep patterns assessed using accelerometers
Time Frame
10 weeks
Title
Sleep
Description
Sleep patterns assessed using accelerometers
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine A Yandell, PhD
Phone
+61 8 83022109
Email
catherine.yandell@unisa.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Alison M Coates, PhD
Phone
+61 8 83022313
Email
alison.coates@unisa.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Buckley, PhD
Organizational Affiliation
University of South Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Australia Clinical Trial Facility
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine A Yandell, PhD
Phone
+61 8 83022108
Email
catherine.yandell@unisa.edu.au
First Name & Middle Initial & Last Name & Degree
Louise Massie
Phone
+61 8 83022097
Email
louise.massie@unisa.edu.au
First Name & Middle Initial & Last Name & Degree
Jonathan Buckley, PhD
First Name & Middle Initial & Last Name & Degree
Alison M Coates, PhD
First Name & Middle Initial & Last Name & Degree
Alison M Hill, PhD
First Name & Middle Initial & Last Name & Degree
Sharayah Carter, PhD
First Name & Middle Initial & Last Name & Degree
Catherine A Yandell, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
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