CompletedNot Applicable

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

Colombia105 participantsStarted 2019-10-11

Plain-language 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.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total cholesterol

Timeframe: Change from Baseline Total cholesterol at 8 weeks

Low-density lipoprotein (LDL) cholesterol

Timeframe: Change from Baseline LDL cholesterol at 8 weeks

Very low-density lipoprotein (VLDL) cholesterol

Timeframe: Change from Baseline VLDL cholesterol at 8 weeks

Triglycerides

Timeframe: Change from Baseline Triglycerides at 8 weeks

High-density lipoprotein (HLDL) cholesterol

Timeframe: Change from Baseline HDL cholesterol at 8 weeks

Glucose

Timeframe: Change from Baseline Glucose at 8 weeks

Systolic Blood Pressure

Timeframe: Change from Baseline Systolic Blood Pressure at 8 weeks

Trial details

NCT IDNCT05088577

SponsorUniversidad de Antioquia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-18

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