An interventional study of Whole egg and Annatto-enriched egg in Healthy Volunteers, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Basic science
Healthy adult volunteers (n= 105; 18-59 years) were randomly allocated to consume daily for 8 weeks, either two whole eggs (egg group), two whole eggs added with annatto (annatto-enriched egg group), or two egg whites (control). Volunteers were asked to continue with the habitual physical activity and diet, except for the consumption of additional eggs, egg whites or annatto.
It is hypothesized that participants consuming eggs would have a less atherogenic lipid profile, feel more satisfied and increase antioxidant levels in blood, compared to the control group. Participants in the annatto-enriched egg group would have greater antioxidant capacity than the egg group and compared to control.
Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two whole eggs (50g each) to be eaten daily during 8 weeks
Dietary Supplement: Whole egg
Two whole eggs (50g each) enriched with annatto (Bixa orellana L.) to be eaten daily during 8 weeks. Dose of annatto: 1,2 mg bixin/kg of body weight.
Dietary Supplement: Annatto-enriched egg
Two egg whites to be eaten daily during 8 weeks
Dietary Supplement: Egg whites - Control
Daily consumption of two whole eggs during 8 weeks
Daily consumption of two whole eggs enriched with annatto during 8 weeks
Daily consumption of two eggs whites during 8 weeks
Total cholesterol
Fasting blood total cholesterol in mg/dL
Time frame: Change from Baseline Total cholesterol at 8 weeks
Low-density lipoprotein (LDL) cholesterol
Fasting blood LDL cholesterol in mg/dL
Time frame: Change from Baseline LDL cholesterol at 8 weeks
Very low-density lipoprotein (VLDL) cholesterol
Fasting blood VLDL cholesterol in mg/dL
Time frame: Change from Baseline VLDL cholesterol at 8 weeks
Triglycerides
Fasting blood triglycerides in mg/dL
Time frame: Change from Baseline Triglycerides at 8 weeks
High-density lipoprotein (HLDL) cholesterol
Fasting blood HLDL cholesterol in mg/dL
Time frame: Change from Baseline HDL cholesterol at 8 weeks
Glucose
Fasting blood glucose in mg/dL
Time frame: Change from Baseline Glucose at 8 weeks
Systolic Blood Pressure
Systolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 130 mmHg
Time frame: Change from Baseline Systolic Blood Pressure at 8 weeks
Diastolic Blood Pressure
Diastolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 85 mmHg
Time frame: Change from Baseline Diastolic Blood Pressure at 8 weeks
Body Mass Index (BMI) in kg/m^2: weight in kilograms, height in meters
weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from Baseline BMI at 8 weeks
Waist circumference
Waist circumference in centimeters measured at the superior border of the iliac crest
Time frame: Change from Baseline Waist circumference at 8 weeks
Blood lutein levels
Fasting blood lutein levels in micrograms per mL
Time frame: Change from Baseline Blood lutein levels at 8 weeks
Dietary lutein+zeaxanthin levels
Dietary lutein+zeaxanthin levels in micrograms
Time frame: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Blood bixin levels
Fasting blood bixin levels in %
Time frame: Change from Baseline Blood bixin levels at 8 weeks
Triglyceride-Rich lipoprotein (TRLP) size
Fasting blood subclasses (Large, medium, small) of TRLP in nmol/L measured by Nuclear Magnetic Resonance
Time frame: Change from Baseline TRLP size at 8 weeks
Low-density lipoprotein (LDL) size
Fasting blood subclasses (Large, medium, small) of LDL in nmol/L measured by Nuclear Magnetic Resonance
Time frame: Change from Baseline LDL size at 8 weeks
High-density lipoprotein (HDL) size
Fasting blood subclasses (Large, medium, small) of HDL in μmol/L measured by Nuclear Magnetic Resonance
Time frame: Change from Baseline HDL size at 8 weeks
Apolipoprotein B (ApoB)
Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance
Time frame: Change from Baseline ApoB at 8 weeks
Apolipoprotein A1 (ApoA1)
Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance
Time frame: Change from Baseline ApoA1 at 8 weeks
Ghrelin
Ghrelin in pg/mL
Time frame: Change from Baseline Ghrelin at 8 weeks
Visual Analog Scale (VAS) to Measure Perceived Hunger and Satiety
"Visual Analog Scale to measure perceived hunger and satiety" to complete in the morning, fasting, 5 days before entering the study and the last 5 days to end the study (8th week). The VAS consist of 8 questions followed each by a line of 10cm in which the person marks a position corresponding to his/her feelings about hunger and satiety. A higher score (10) means the person feels with more hunger or satisfied.
Time frame: Change from Baseline VAS of Hunger and Satiety at 8 weeks
Ancestry Informative Marker
Percentage of genetic ethnicity of European, Amerindian and African for each participant
Time frame: Baseline
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Universidad de Antioquia