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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Whole egg; Dietary supplement: Annatto-enriched egg; Dietary supplement: Egg whites - Control

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Sede de Investigación Universitaria - Universidad de Antioquia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole egg; Two whole eggs (50g each) to be eaten daily during 8 weeks	Dietary supplement: Whole egg; Daily consumption of two whole eggs during 8 weeks
Experimental: Annatto-enriched 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; Daily consumption of two whole eggs enriched with annatto during 8 weeks
Placebo Comparator: Egg whites - Control; Two egg whites to be eaten daily during 8 weeks	Dietary supplement: Egg whites - Control; Daily consumption of two eggs whites during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Fasting blood total cholesterol in mg/dL	Change from Baseline Total cholesterol at 8 weeks
Low-density lipoprotein (LDL) cholesterol	Fasting blood LDL cholesterol in mg/dL	Change from Baseline LDL cholesterol at 8 weeks
Very low-density lipoprotein (VLDL) cholesterol	Fasting blood VLDL cholesterol in mg/dL	Change from Baseline VLDL cholesterol at 8 weeks
Triglycerides	Fasting blood triglycerides in mg/dL	Change from Baseline Triglycerides at 8 weeks
High-density lipoprotein (HLDL) cholesterol	Fasting blood HLDL cholesterol in mg/dL	Change from Baseline HDL cholesterol at 8 weeks
Glucose	Fasting blood glucose in mg/dL	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	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	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	Change from Baseline BMI at 8 weeks
Waist circumference	Waist circumference in centimeters measured at the superior border of the iliac crest	Change from Baseline Waist circumference at 8 weeks
Blood lutein levels	Fasting blood lutein levels in micrograms per mL	Change from Baseline Blood lutein levels at 8 weeks
Dietary lutein+zeaxanthin levels	Dietary lutein+zeaxanthin levels in micrograms	Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Blood bixin levels	Fasting blood bixin levels in %	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	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	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	Change from Baseline HDL size at 8 weeks
Apolipoprotein B (ApoB)	Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance	Change from Baseline ApoB at 8 weeks
Apolipoprotein A1 (ApoA1)	Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance	Change from Baseline ApoA1 at 8 weeks
Ghrelin	Ghrelin in pg/mL	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.	Change from Baseline VAS of Hunger and Satiety at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ancestry Informative Marker	Percentage of genetic ethnicity of European, Amerindian and African for each participant	Baseline

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Collaborators: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
• Investigators: Principal Investigator: Jacqueline Barona-Acevedo, PhD, Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: clinical trial; cardiovascular risk factors; Egg; Bixa orellana; Annatto
• Other Study ID Numbers: 754-2018; 111580763245 (Other Grant/Funding Number: Minciencias)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No