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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05267522




Registration number
NCT05267522
Ethics application status
Date submitted
2/02/2022
Date registered
4/03/2022
Date last updated
13/12/2023

Titles & IDs
Public title
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Scientific title
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Secondary ID [1] 0 0
204327
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Hyperlipidemias 0 0
Physical Inactivity 0 0
Diet, Healthy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Egg diet
Other interventions - Egg-free Diet
Other interventions - Control Diet

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.

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.

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 interventions: Egg diet
30% fat \[6% saturated fat\], 20% protein, 40% carbohydrate, 600 mg cholesterol

Other interventions: Egg-free Diet
30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 300 mg cholesterol

Other interventions: Control Diet
30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 600 mg cholesterol
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [2] 0 0
5 weeks
Primary outcome [3] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [3] 0 0
10 weeks
Primary outcome [4] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [4] 0 0
15 weeks
Secondary outcome [1] 0 0
Blood lipid profiling
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Blood lipid profiling
Timepoint [2] 0 0
5 weeks
Secondary outcome [3] 0 0
Blood lipid profiling
Timepoint [3] 0 0
10 weeks
Secondary outcome [4] 0 0
Blood lipid profiling
Timepoint [4] 0 0
15 weeks
Secondary outcome [5] 0 0
Fasting glucose
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Fasting glucose
Timepoint [6] 0 0
5 weeks
Secondary outcome [7] 0 0
Fasting glucose
Timepoint [7] 0 0
10 weeks
Secondary outcome [8] 0 0
Fasting glucose
Timepoint [8] 0 0
15 weeks
Secondary outcome [9] 0 0
Physical activity levels
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Physical activity levels
Timepoint [10] 0 0
5 weeks
Secondary outcome [11] 0 0
Physical activity levels
Timepoint [11] 0 0
10 weeks
Secondary outcome [12] 0 0
Physical activity levels
Timepoint [12] 0 0
15 weeks
Secondary outcome [13] 0 0
Waist circumference
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Waist circumference
Timepoint [14] 0 0
5 weeks
Secondary outcome [15] 0 0
Waist circumference
Timepoint [15] 0 0
10 weeks
Secondary outcome [16] 0 0
Waist circumference
Timepoint [16] 0 0
15 weeks
Secondary outcome [17] 0 0
Blood Pressure
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Blood Pressure
Timepoint [18] 0 0
5 weeks
Secondary outcome [19] 0 0
Blood Pressure
Timepoint [19] 0 0
10 weeks
Secondary outcome [20] 0 0
Blood Pressure
Timepoint [20] 0 0
15 weeks
Secondary outcome [21] 0 0
Dietary saturated fat intake
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Dietary saturated fat intake
Timepoint [22] 0 0
5 weeks
Secondary outcome [23] 0 0
Dietary saturated fat intake
Timepoint [23] 0 0
10 weeks
Secondary outcome [24] 0 0
Dietary saturated fat intake
Timepoint [24] 0 0
15 weeks
Secondary outcome [25] 0 0
Dietary cholesterol intake
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Dietary cholesterol intake
Timepoint [26] 0 0
5 weeks
Secondary outcome [27] 0 0
Dietary cholesterol intake
Timepoint [27] 0 0
10 weeks
Secondary outcome [28] 0 0
Dietary cholesterol intake
Timepoint [28] 0 0
15 weeks
Secondary outcome [29] 0 0
Dietary Energy intake
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Dietary Energy intake
Timepoint [30] 0 0
5 weeks
Secondary outcome [31] 0 0
Dietary Energy intake
Timepoint [31] 0 0
10 weeks
Secondary outcome [32] 0 0
Dietary Energy intake
Timepoint [32] 0 0
15 weeks
Secondary outcome [33] 0 0
Dietary Macronutrients
Timepoint [33] 0 0
Baseline
Secondary outcome [34] 0 0
Dietary Macronutrients
Timepoint [34] 0 0
5 weeks
Secondary outcome [35] 0 0
Dietary Macronutrients
Timepoint [35] 0 0
10 weeks
Secondary outcome [36] 0 0
Dietary Macronutrients
Timepoint [36] 0 0
15 weeks
Secondary outcome [37] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [37] 0 0
Baseline
Secondary outcome [38] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [38] 0 0
5 weeks
Secondary outcome [39] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [39] 0 0
10 weeks
Secondary outcome [40] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [40] 0 0
15 weeks
Secondary outcome [41] 0 0
Sleep
Timepoint [41] 0 0
Baseline
Secondary outcome [42] 0 0
Sleep
Timepoint [42] 0 0
5 weeks
Secondary outcome [43] 0 0
Sleep
Timepoint [43] 0 0
10 weeks
Secondary outcome [44] 0 0
Sleep
Timepoint [44] 0 0
15 weeks

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2023
Sample size
Target
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia Clinical Trial Facility - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Egg Board
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05267522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan D Buckley, PhD
Address 0 0
University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05267522