Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults
NCT ID: NCT05088577
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
105 participants
INTERVENTIONAL
2019-10-11
2020-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Whole egg
Two whole eggs (50g each) to be eaten daily during 8 weeks
Whole egg
Daily consumption of two whole eggs during 8 weeks
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.
Annatto-enriched egg
Daily consumption of two whole eggs enriched with annatto during 8 weeks
Egg whites - Control
Two egg whites to be eaten daily during 8 weeks
Egg whites - Control
Daily consumption of two eggs whites during 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Whole egg
Daily consumption of two whole eggs during 8 weeks
Annatto-enriched egg
Daily consumption of two whole eggs enriched with annatto during 8 weeks
Egg whites - Control
Daily consumption of two eggs whites during 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
OTHER_GOV
Universidad de Antioquia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jacqueline Barona Acevedo
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacqueline Barona-Acevedo, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Antioquia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sede de Investigación Universitaria - Universidad de Antioquia
Medellín, Antioquia, Colombia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
111580763245
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
754-2018
Identifier Type: -
Identifier Source: org_study_id