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Completed

NCT Number: NCT05267522

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

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Australia Clinical Trial Facility

Adelaide, South Australia, 5000, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Egg diet

Other

30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol

Other names: High cholesterol + low saturated fat diet

Egg-free Diet

Other

30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol

Other names: Low cholesterol + high saturated fat diet

Control diet

Other

30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol

Other names: Average Australian Diet

Primary outcomes

  1. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline

    Plasma LDL-C levels (mmol/L)

  2. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: 5 weeks

    Plasma LDL-C levels (mmol/L)

  3. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: 10 weeks

    Plasma LDL-C levels (mmol/L)

  4. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: 15 weeks

    Plasma LDL-C levels (mmol/L)

Secondary outcomes

  1. Blood lipid profiling

    Time frame: Baseline

    Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins

  2. Blood lipid profiling

    Time frame: 5 weeks

    Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins

  3. Blood lipid profiling

    Time frame: 10 weeks

    Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins

  4. Blood lipid profiling

    Time frame: 15 weeks

    Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins

  5. Fasting glucose

    Time frame: Baseline

    Plasma glucose levels (mmol/L)

  6. Fasting glucose

    Time frame: 5 weeks

    Plasma glucose levels (mmol/L)

  7. Fasting glucose

    Time frame: 10 weeks

    Plasma glucose levels (mmol/L)

  8. Fasting glucose

    Time frame: 15 weeks

    Plasma glucose levels (mmol/L)

  9. Physical activity levels

    Time frame: Baseline

    Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity

  10. Physical activity levels

    Time frame: 5 weeks

    Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity

  11. Physical activity levels

    Time frame: 10 weeks

    Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity

  12. Physical activity levels

    Time frame: 15 weeks

    Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity

  13. Waist circumference

    Time frame: Baseline

    Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.

  14. Waist circumference

    Time frame: 5 weeks

    Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.

  15. Waist circumference

    Time frame: 10 weeks

    Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.

  16. Waist circumference

    Time frame: 15 weeks

    Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.

  17. Blood Pressure

    Time frame: Baseline

    Seated blood pressure (mmHg)

  18. Blood Pressure

    Time frame: 5 weeks

    Seated blood pressure (mmHg)

  19. Blood Pressure

    Time frame: 10 weeks

    Seated blood pressure (mmHg)

  20. Blood Pressure

    Time frame: 15 weeks

    Seated blood pressure (mmHg)

  21. Dietary saturated fat intake

    Time frame: Baseline

    Analysis of dietary intake based on 5-day food diaries

  22. Dietary saturated fat intake

    Time frame: 5 weeks

    Analysis of dietary intake based on 5-day food diaries

  23. Dietary saturated fat intake

    Time frame: 10 weeks

    Analysis of dietary intake based on 5-day food diaries

  24. Dietary saturated fat intake

    Time frame: 15 weeks

    Analysis of dietary intake based on 5-day food diaries

  25. Dietary cholesterol intake

    Time frame: Baseline

    Analysis of dietary intake based on 5-day food diaries

  26. Dietary cholesterol intake

    Time frame: 5 weeks

    Analysis of dietary intake based on 5-day food diaries

  27. Dietary cholesterol intake

    Time frame: 10 weeks

    Analysis of dietary intake based on 5-day food diaries

  28. Dietary cholesterol intake

    Time frame: 15 weeks

    Analysis of dietary intake based on 5-day food diaries

  29. Dietary Energy intake

    Time frame: Baseline

    Analysis of dietary intake based on 5-day food diaries

  30. Dietary Energy intake

    Time frame: 5 weeks

    Analysis of dietary intake based on 5-day food diaries

  31. Dietary Energy intake

    Time frame: 10 weeks

    Analysis of dietary intake based on 5-day food diaries

  32. Dietary Energy intake

    Time frame: 15 weeks

    Analysis of dietary intake based on 5-day food diaries

  33. Dietary Macronutrients

    Time frame: Baseline

    Analysis of dietary intake based on food diaries

  34. Dietary Macronutrients

    Time frame: 5 weeks

    Analysis of dietary intake based on food diaries

  35. Dietary Macronutrients

    Time frame: 10 weeks

    Analysis of dietary intake based on food diaries

  36. Dietary Macronutrients

    Time frame: 15 weeks

    Analysis of dietary intake based on food diaries

  37. Dietary Lutein+Zeaxanthin

    Time frame: Baseline

    Analysis of dietary intake based on food diaries

  38. Dietary Lutein+Zeaxanthin

    Time frame: 5 weeks

    Analysis of dietary intake based on food diaries

  39. Dietary Lutein+Zeaxanthin

    Time frame: 10 weeks

    Analysis of dietary intake based on food diaries

  40. Dietary Lutein+Zeaxanthin

    Time frame: 15 weeks

    Analysis of dietary intake based on food diaries

  41. Sleep

    Time frame: Baseline

    Sleep patterns assessed using accelerometers

  42. Sleep

    Time frame: 5 weeks

    Sleep patterns assessed using accelerometers

  43. Sleep

    Time frame: 10 weeks

    Sleep patterns assessed using accelerometers

  44. Sleep

    Time frame: 15 weeks

    Sleep patterns assessed using accelerometers

Sponsors and collaborators

Lead sponsor

University of South Australia

Other

Collaborators

  • American Egg Board

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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