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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Whole egg
* Dietary Supplement: Annatto-enriched egg
* Dietary Supplement: Egg whites - Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egg, Bixa orellana, Annatto, cardiovascular risk factors, clinical trial