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 range18 Years – 59 Years

SexALL

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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.

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

Diastolic Blood Pressure

Timeframe: Change from Baseline Diastolic Blood Pressure at 8 weeks

Trial details

NCT IDNCT05088577

SponsorUniversidad de Antioquia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-18

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