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

December 11, 2023 updated by: Prof. Jonathan Buckley, University of South Australia
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • University of South Australia Clinical Trial Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Egg Diet
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
30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol
Other Names:
  • High cholesterol + low saturated fat diet
Active Comparator: Egg-free Diet
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
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol
Other Names:
  • Low cholesterol + high saturated fat diet
Active Comparator: Control Diet
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
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol
Other Names:
  • Average Australian Diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline
Plasma LDL-C levels (mmol/L)
Baseline
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 5 weeks
Plasma LDL-C levels (mmol/L)
5 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 10 weeks
Plasma LDL-C levels (mmol/L)
10 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 15 weeks
Plasma LDL-C levels (mmol/L)
15 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood lipid profiling
Time Frame: Baseline
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Baseline
Blood lipid profiling
Time Frame: 5 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
5 weeks
Blood lipid profiling
Time Frame: 10 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
10 weeks
Blood lipid profiling
Time Frame: 15 weeks
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
15 weeks
Fasting glucose
Time Frame: Baseline
Plasma glucose levels (mmol/L)
Baseline
Fasting glucose
Time Frame: 5 weeks
Plasma glucose levels (mmol/L)
5 weeks
Fasting glucose
Time Frame: 10 weeks
Plasma glucose levels (mmol/L)
10 weeks
Fasting glucose
Time Frame: 15 weeks
Plasma glucose levels (mmol/L)
15 weeks
Physical activity levels
Time Frame: Baseline
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Baseline
Physical activity levels
Time Frame: 5 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
5 weeks
Physical activity levels
Time Frame: 10 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
10 weeks
Physical activity levels
Time Frame: 15 weeks
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
15 weeks
Waist circumference
Time Frame: Baseline
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Baseline
Waist circumference
Time Frame: 5 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
5 weeks
Waist circumference
Time Frame: 10 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
10 weeks
Waist circumference
Time Frame: 15 weeks
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
15 weeks
Blood Pressure
Time Frame: Baseline
Seated blood pressure (mmHg)
Baseline
Blood Pressure
Time Frame: 5 weeks
Seated blood pressure (mmHg)
5 weeks
Blood Pressure
Time Frame: 10 weeks
Seated blood pressure (mmHg)
10 weeks
Blood Pressure
Time Frame: 15 weeks
Seated blood pressure (mmHg)
15 weeks
Dietary saturated fat intake
Time Frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Baseline
Dietary saturated fat intake
Time Frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
5 weeks
Dietary saturated fat intake
Time Frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
10 weeks
Dietary saturated fat intake
Time Frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
15 weeks
Dietary cholesterol intake
Time Frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Baseline
Dietary cholesterol intake
Time Frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
5 weeks
Dietary cholesterol intake
Time Frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
10 weeks
Dietary cholesterol intake
Time Frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
15 weeks
Dietary Energy intake
Time Frame: Baseline
Analysis of dietary intake based on 5-day food diaries
Baseline
Dietary Energy intake
Time Frame: 5 weeks
Analysis of dietary intake based on 5-day food diaries
5 weeks
Dietary Energy intake
Time Frame: 10 weeks
Analysis of dietary intake based on 5-day food diaries
10 weeks
Dietary Energy intake
Time Frame: 15 weeks
Analysis of dietary intake based on 5-day food diaries
15 weeks
Dietary Macronutrients
Time Frame: Baseline
Analysis of dietary intake based on food diaries
Baseline
Dietary Macronutrients
Time Frame: 5 weeks
Analysis of dietary intake based on food diaries
5 weeks
Dietary Macronutrients
Time Frame: 10 weeks
Analysis of dietary intake based on food diaries
10 weeks
Dietary Macronutrients
Time Frame: 15 weeks
Analysis of dietary intake based on food diaries
15 weeks
Dietary Lutein+Zeaxanthin
Time Frame: Baseline
Analysis of dietary intake based on food diaries
Baseline
Dietary Lutein+Zeaxanthin
Time Frame: 5 weeks
Analysis of dietary intake based on food diaries
5 weeks
Dietary Lutein+Zeaxanthin
Time Frame: 10 weeks
Analysis of dietary intake based on food diaries
10 weeks
Dietary Lutein+Zeaxanthin
Time Frame: 15 weeks
Analysis of dietary intake based on food diaries
15 weeks
Sleep
Time Frame: Baseline
Sleep patterns assessed using accelerometers
Baseline
Sleep
Time Frame: 5 weeks
Sleep patterns assessed using accelerometers
5 weeks
Sleep
Time Frame: 10 weeks
Sleep patterns assessed using accelerometers
10 weeks
Sleep
Time Frame: 15 weeks
Sleep patterns assessed using accelerometers
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Australia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Egg Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan D Buckley, PhD, University of South Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 204327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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