Healthy Volunteers
Conditions
Keywords
Egg, Bixa orellana, Annatto, cardiovascular risk factors, clinical trial
Brief 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.
Interventions
DIETARY_SUPPLEMENTWhole egg
Daily consumption of two whole eggs during 8 weeks
DIETARY_SUPPLEMENTAnnatto-enriched egg
Daily consumption of two whole eggs enriched with annatto during 8 weeks
DIETARY_SUPPLEMENTEgg whites - Control
Daily consumption of two eggs whites during 8 weeks
Sponsors
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) to Measure Perceived Hunger and Satiety | Change from Baseline VAS of Hunger and Satiety at 8 weeks | 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. |
| Blood bixin levels | Change from Baseline Blood bixin levels at 8 weeks | Fasting blood bixin levels in % |
| Total cholesterol | Change from Baseline Total cholesterol at 8 weeks | Fasting blood total cholesterol in mg/dL |
| Low-density lipoprotein (LDL) cholesterol | Change from Baseline LDL cholesterol at 8 weeks | Fasting blood LDL cholesterol in mg/dL |
| Very low-density lipoprotein (VLDL) cholesterol | Change from Baseline VLDL cholesterol at 8 weeks | Fasting blood VLDL cholesterol in mg/dL |
| Triglycerides | Change from Baseline Triglycerides at 8 weeks | Fasting blood triglycerides in mg/dL |
| High-density lipoprotein (HLDL) cholesterol | Change from Baseline HDL cholesterol at 8 weeks | Fasting blood HLDL cholesterol in mg/dL |
| Glucose | Change from Baseline Glucose at 8 weeks | Fasting blood glucose in mg/dL |
| Systolic Blood Pressure | Change from Baseline Systolic Blood Pressure at 8 weeks | Systolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 130 mmHg |
| Diastolic Blood Pressure | Change from Baseline Diastolic Blood Pressure at 8 weeks | Diastolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 85 mmHg |
| Body Mass Index (BMI) in kg/m^2: weight in kilograms, height in meters | Change from Baseline BMI at 8 weeks | weight and height will be combined to report BMI in kg/m\^2 |
| Waist circumference | Change from Baseline Waist circumference at 8 weeks | Waist circumference in centimeters measured at the superior border of the iliac crest |
| Blood lutein levels | Change from Baseline Blood lutein levels at 8 weeks | Fasting blood lutein levels in micrograms per mL |
| Dietary lutein+zeaxanthin levels | Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks | Dietary lutein+zeaxanthin levels in micrograms |
| Triglyceride-Rich lipoprotein (TRLP) size | Change from Baseline TRLP size at 8 weeks | Fasting blood subclasses (Large, medium, small) of TRLP in nmol/L measured by Nuclear Magnetic Resonance |
| Low-density lipoprotein (LDL) size | Change from Baseline LDL size at 8 weeks | Fasting blood subclasses (Large, medium, small) of LDL in nmol/L measured by Nuclear Magnetic Resonance |
| High-density lipoprotein (HDL) size | Change from Baseline HDL size at 8 weeks | Fasting blood subclasses (Large, medium, small) of HDL in μmol/L measured by Nuclear Magnetic Resonance |
| Apolipoprotein B (ApoB) | Change from Baseline ApoB at 8 weeks | Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance |
| Apolipoprotein A1 (ApoA1) | Change from Baseline ApoA1 at 8 weeks | Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance |
| Ghrelin | Change from Baseline Ghrelin at 8 weeks | Ghrelin in pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ancestry Informative Marker | Baseline | Percentage of genetic ethnicity of European, Amerindian and African for each participant |
Countries
Colombia
Outcome results
None listed