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

Universidad de Antioquia105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

105

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Ancestry Informative Marker

Percentage of genetic ethnicity of European, Amerindian and African for each participant

Time frame: Baseline