Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults

Healthy Volunteers Clinical Trial

— EGGANT  

Official title:

Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088577
• Other study ID #: 754-2018
• Secondary ID: 111580763245
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: December 18, 2020

Study information

• Verified date: October 2021
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Age: 18-59 years

• Body Mass Index (BMI): 18,5 - 29,9 kg/m2

• Healthy volunteers

• Good disposition to consume either eggs, egg whites or eggs added with annatto

• To have signed the informed consent

Exclusion Criteria:

• Fasting blood triglycerides > 500mg/dL, Total Cholesterol > 240mg/dL, glucose > 126mg/dL or diabetes.

• Blood pressure: >140/90 mmHg.

• History or having any of the following: liver, kidney, or heart disease, cancer, endocrine or gastrointestinal disorders -especially those that limit food absorption.

• Use of medications to lower blood lipids or glucose.

• Consumption of multivitamins or nutraceuticals.

• Plan to lose body weight, pregnancy or breastfeeding.

• Any known allergy or intolerance to eggs or annatto.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Whole egg
Daily consumption of two whole eggs during 8 weeks
• Annatto-enriched egg
Daily consumption of two whole eggs enriched with annatto during 8 weeks
• Egg whites - Control
Daily consumption of two eggs whites during 8 weeks

Locations

Country	Name	City	State
Colombia	Sede de Investigación Universitaria - Universidad de Antioquia	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol	Fasting blood total cholesterol in mg/dL	Change from Baseline Total cholesterol at 8 weeks
Primary	Low-density lipoprotein (LDL) cholesterol	Fasting blood LDL cholesterol in mg/dL	Change from Baseline LDL cholesterol at 8 weeks
Primary	Very low-density lipoprotein (VLDL) cholesterol	Fasting blood VLDL cholesterol in mg/dL	Change from Baseline VLDL cholesterol at 8 weeks
Primary	Triglycerides	Fasting blood triglycerides in mg/dL	Change from Baseline Triglycerides at 8 weeks
Primary	High-density lipoprotein (HLDL) cholesterol	Fasting blood HLDL cholesterol in mg/dL	Change from Baseline HDL cholesterol at 8 weeks
Primary	Glucose	Fasting blood glucose in mg/dL	Change from Baseline Glucose at 8 weeks
Primary	Systolic Blood Pressure	Systolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 130 mmHg	Change from Baseline Systolic Blood Pressure at 8 weeks
Primary	Diastolic Blood Pressure	Diastolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 85 mmHg	Change from Baseline Diastolic Blood Pressure at 8 weeks
Primary	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	Change from Baseline BMI at 8 weeks
Primary	Waist circumference	Waist circumference in centimeters measured at the superior border of the iliac crest	Change from Baseline Waist circumference at 8 weeks
Primary	Blood lutein levels	Fasting blood lutein levels in micrograms per mL	Change from Baseline Blood lutein levels at 8 weeks
Primary	Dietary lutein+zeaxanthin levels	Dietary lutein+zeaxanthin levels in micrograms	Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Primary	Blood bixin levels	Fasting blood bixin levels in %	Change from Baseline Blood bixin levels at 8 weeks
Primary	Triglyceride-Rich lipoprotein (TRLP) size	Fasting blood subclasses (Large, medium, small) of TRLP in nmol/L measured by Nuclear Magnetic Resonance	Change from Baseline TRLP size at 8 weeks
Primary	Low-density lipoprotein (LDL) size	Fasting blood subclasses (Large, medium, small) of LDL in nmol/L measured by Nuclear Magnetic Resonance	Change from Baseline LDL size at 8 weeks
Primary	High-density lipoprotein (HDL) size	Fasting blood subclasses (Large, medium, small) of HDL in µmol/L measured by Nuclear Magnetic Resonance	Change from Baseline HDL size at 8 weeks
Primary	Apolipoprotein B (ApoB)	Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance	Change from Baseline ApoB at 8 weeks
Primary	Apolipoprotein A1 (ApoA1)	Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance	Change from Baseline ApoA1 at 8 weeks
Primary	Ghrelin	Ghrelin in pg/mL	Change from Baseline Ghrelin at 8 weeks
Primary	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.	Change from Baseline VAS of Hunger and Satiety at 8 weeks
Secondary	Ancestry Informative Marker	Percentage of genetic ethnicity of European, Amerindian and African for each participant	Baseline