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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
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Secondary ID [1]
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204327
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
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Hyperlipidemias
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Physical Inactivity
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Diet, Healthy
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Low-density lipoprotein cholesterol (LDL-C)
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Assessment method [1]
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Plasma LDL-C levels (mmol/L)
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Low-density lipoprotein cholesterol (LDL-C)
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Assessment method [2]
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Plasma LDL-C levels (mmol/L)
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Timepoint [2]
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5 weeks
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Primary outcome [3]
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Low-density lipoprotein cholesterol (LDL-C)
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Assessment method [3]
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Plasma LDL-C levels (mmol/L)
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Timepoint [3]
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10 weeks
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Primary outcome [4]
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Low-density lipoprotein cholesterol (LDL-C)
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Assessment method [4]
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Plasma LDL-C levels (mmol/L)
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Timepoint [4]
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15 weeks
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Secondary outcome [1]
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Blood lipid profiling
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Assessment method [1]
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Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Blood lipid profiling
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Assessment method [2]
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Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
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Timepoint [2]
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5 weeks
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Secondary outcome [3]
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Blood lipid profiling
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Assessment method [3]
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Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
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Timepoint [3]
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10 weeks
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Secondary outcome [4]
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Blood lipid profiling
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Assessment method [4]
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Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
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Timepoint [4]
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15 weeks
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Secondary outcome [5]
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Fasting glucose
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Assessment method [5]
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Plasma glucose levels (mmol/L)
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Fasting glucose
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Assessment method [6]
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Plasma glucose levels (mmol/L)
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Timepoint [6]
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5 weeks
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Secondary outcome [7]
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Fasting glucose
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Assessment method [7]
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Plasma glucose levels (mmol/L)
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Timepoint [7]
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10 weeks
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Secondary outcome [8]
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Fasting glucose
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Assessment method [8]
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Plasma glucose levels (mmol/L)
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Timepoint [8]
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15 weeks
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Secondary outcome [9]
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Physical activity levels
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Assessment method [9]
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Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Physical activity levels
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Assessment method [10]
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Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
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Timepoint [10]
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5 weeks
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Secondary outcome [11]
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Physical activity levels
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Assessment method [11]
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Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
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Timepoint [11]
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10 weeks
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Secondary outcome [12]
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Physical activity levels
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Assessment method [12]
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Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
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Timepoint [12]
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15 weeks
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Secondary outcome [13]
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Waist circumference
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Assessment method [13]
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Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Waist circumference
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Assessment method [14]
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Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
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Timepoint [14]
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5 weeks
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Secondary outcome [15]
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Waist circumference
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Assessment method [15]
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Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
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Timepoint [15]
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10 weeks
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Secondary outcome [16]
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Waist circumference
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Assessment method [16]
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Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
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Timepoint [16]
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15 weeks
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Secondary outcome [17]
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Blood Pressure
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Assessment method [17]
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Seated blood pressure (mmHg)
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Timepoint [17]
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Baseline
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Secondary outcome [18]
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Blood Pressure
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Assessment method [18]
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Seated blood pressure (mmHg)
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Timepoint [18]
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5 weeks
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Secondary outcome [19]
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Blood Pressure
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Assessment method [19]
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Seated blood pressure (mmHg)
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Timepoint [19]
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10 weeks
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Secondary outcome [20]
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Blood Pressure
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Assessment method [20]
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Seated blood pressure (mmHg)
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Timepoint [20]
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15 weeks
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Secondary outcome [21]
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Dietary saturated fat intake
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Assessment method [21]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [21]
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Baseline
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Secondary outcome [22]
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Dietary saturated fat intake
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Assessment method [22]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [22]
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5 weeks
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Secondary outcome [23]
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Dietary saturated fat intake
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Assessment method [23]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [23]
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10 weeks
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Secondary outcome [24]
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Dietary saturated fat intake
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Assessment method [24]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [24]
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15 weeks
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Secondary outcome [25]
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Dietary cholesterol intake
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Assessment method [25]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [25]
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Baseline
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Secondary outcome [26]
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Dietary cholesterol intake
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Assessment method [26]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [26]
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5 weeks
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Secondary outcome [27]
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Dietary cholesterol intake
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Assessment method [27]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [27]
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10 weeks
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Secondary outcome [28]
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Dietary cholesterol intake
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Assessment method [28]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [28]
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15 weeks
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Secondary outcome [29]
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Dietary Energy intake
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Assessment method [29]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [29]
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Baseline
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Secondary outcome [30]
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Dietary Energy intake
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Assessment method [30]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [30]
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5 weeks
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Secondary outcome [31]
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Dietary Energy intake
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Assessment method [31]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [31]
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10 weeks
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Secondary outcome [32]
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Dietary Energy intake
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Assessment method [32]
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Analysis of dietary intake based on 5-day food diaries
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Timepoint [32]
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15 weeks
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Secondary outcome [33]
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Dietary Macronutrients
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Assessment method [33]
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Analysis of dietary intake based on food diaries
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Timepoint [33]
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Baseline
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Secondary outcome [34]
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Dietary Macronutrients
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Assessment method [34]
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Analysis of dietary intake based on food diaries
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Timepoint [34]
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5 weeks
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Secondary outcome [35]
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Dietary Macronutrients
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Assessment method [35]
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Analysis of dietary intake based on food diaries
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Timepoint [35]
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10 weeks
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Secondary outcome [36]
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Dietary Macronutrients
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Assessment method [36]
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Analysis of dietary intake based on food diaries
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Timepoint [36]
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15 weeks
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Secondary outcome [37]
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Dietary Lutein+Zeaxanthin
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Assessment method [37]
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Analysis of dietary intake based on food diaries
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Timepoint [37]
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Baseline
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Secondary outcome [38]
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Dietary Lutein+Zeaxanthin
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Assessment method [38]
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Analysis of dietary intake based on food diaries
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Timepoint [38]
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5 weeks
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Secondary outcome [39]
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Dietary Lutein+Zeaxanthin
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Assessment method [39]
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Analysis of dietary intake based on food diaries
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Timepoint [39]
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10 weeks
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Secondary outcome [40]
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Dietary Lutein+Zeaxanthin
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Assessment method [40]
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Analysis of dietary intake based on food diaries
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Timepoint [40]
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15 weeks
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Secondary outcome [41]
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Sleep
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Assessment method [41]
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Sleep patterns assessed using accelerometers
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Timepoint [41]
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Baseline
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Secondary outcome [42]
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Sleep
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Assessment method [42]
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Sleep patterns assessed using accelerometers
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Timepoint [42]
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5 weeks
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Secondary outcome [43]
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Sleep
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Assessment method [43]
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Sleep patterns assessed using accelerometers
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Timepoint [43]
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10 weeks
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Secondary outcome [44]
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Sleep
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Assessment method [44]
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Sleep patterns assessed using accelerometers
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Timepoint [44]
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15 weeks
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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).
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Minimum age
18
Years
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2023
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Sample size
Target
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Accrual to date
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Final
77
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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University of South Australia Clinical Trial Facility - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of South Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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American Egg Board
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05267522
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jonathan D Buckley, PhD
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Address
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University of South Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05267522
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