Status:
COMPLETED
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Lead Sponsor:
University of South Australia
Collaborating Sponsors:
American Egg Board
Conditions:
Hypercholesterolemia
Hyperlipidemias
Eligibility:
All Genders
18-60 years
Phase:
NA
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 f...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05267522
Start Date
March 1 2022
End Date
August 31 2023
Last Update
December 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Australia Clinical Trial Facility
Adelaide, South Australia, Australia, 5000