Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Whole eggDietary Supplement: Annatto-enriched eggDietary Supplement: Egg whites - Control
- Registration Number
- NCT05088577
- Lead Sponsor
- Universidad de Antioquia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole egg Whole egg Two whole eggs (50g each) to be eaten daily during 8 weeks Annatto-enriched egg 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. Egg whites - Control Egg whites - Control Two egg whites to be eaten daily during 8 weeks
- Primary Outcome Measures
Name Time Method Blood lutein levels Change from Baseline Blood lutein levels at 8 weeks Fasting blood lutein levels in micrograms per mL
Blood bixin levels Change from Baseline Blood bixin levels at 8 weeks Fasting blood bixin levels in %
Apolipoprotein B (ApoB) Change from Baseline ApoB at 8 weeks Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance
Total cholesterol Change from Baseline Total cholesterol at 8 weeks Fasting blood total cholesterol 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
Triglycerides Change from Baseline Triglycerides at 8 weeks Fasting blood triglycerides in mg/dL
Very low-density lipoprotein (VLDL) cholesterol Change from Baseline VLDL cholesterol at 8 weeks Fasting blood VLDL cholesterol in mg/dL
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
Low-density lipoprotein (LDL) cholesterol Change from Baseline LDL cholesterol at 8 weeks Fasting blood LDL cholesterol in mg/dL
Waist circumference Change from Baseline Waist circumference at 8 weeks Waist circumference in centimeters measured at the superior border of the iliac crest
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
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
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
Ghrelin Change from Baseline Ghrelin at 8 weeks Ghrelin in pg/mL
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.
Dietary lutein+zeaxanthin levels Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks Dietary lutein+zeaxanthin levels in micrograms
Apolipoprotein A1 (ApoA1) Change from Baseline ApoA1 at 8 weeks Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance
- Secondary Outcome Measures
Name Time Method Ancestry Informative Marker Baseline Percentage of genetic ethnicity of European, Amerindian and African for each participant
Trial Locations
- Locations (1)
Sede de Investigación Universitaria - Universidad de Antioquia
🇨🇴Medellín, Antioquia, Colombia