Clinical trial NCT05088577: Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults
Official title: Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Egg
Bixa orellana
Annatto
cardiovascular risk factors
clinical trial
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2021-10-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total cholesterol
timeFrame: Change from Baseline Total cholesterol at 8 weeks
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Change from Baseline LDL cholesterol at 8 weeks
measure: Very low-density lipoprotein (VLDL) cholesterol
timeFrame: Change from Baseline VLDL cholesterol at 8 weeks
measure: Triglycerides
timeFrame: Change from Baseline Triglycerides at 8 weeks
measure: High-density lipoprotein (HLDL) cholesterol
timeFrame: Change from Baseline HDL cholesterol at 8 weeks
measure: Glucose
timeFrame: Change from Baseline Glucose at 8 weeks
measure: Systolic Blood Pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 8 weeks
measure: Diastolic Blood Pressure
timeFrame: Change from Baseline Diastolic Blood Pressure at 8 weeks
measure: Body Mass Index (BMI) in kg/m^2: weight in kilograms, height in meters
timeFrame: Change from Baseline BMI at 8 weeks
measure: Waist circumference
timeFrame: Change from Baseline Waist circumference at 8 weeks
measure: Blood lutein levels
timeFrame: Change from Baseline Blood lutein levels at 8 weeks
measure: Dietary lutein+zeaxanthin levels
timeFrame: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
measure: Blood bixin levels
timeFrame: Change from Baseline Blood bixin levels at 8 weeks
measure: Triglyceride-Rich lipoprotein (TRLP) size
timeFrame: Change from Baseline TRLP size at 8 weeks
measure: Low-density lipoprotein (LDL) size
timeFrame: Change from Baseline LDL size at 8 weeks
measure: High-density lipoprotein (HDL) size
timeFrame: Change from Baseline HDL size at 8 weeks
measure: Apolipoprotein B (ApoB)
timeFrame: Change from Baseline ApoB at 8 weeks
measure: Apolipoprotein A1 (ApoA1)
timeFrame: Change from Baseline ApoA1 at 8 weeks
measure: Ghrelin
timeFrame: Change from Baseline Ghrelin at 8 weeks
measure: Visual Analog Scale (VAS) to Measure Perceived Hunger and Satiety
timeFrame: Change from Baseline VAS of Hunger and Satiety at 8 weeks
Secondary outcomes:
measure: Ancestry Informative Marker
timeFrame: Baseline
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Sede de Investigación Universitaria - Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Jacqueline Barona-Acevedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: