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

Universidad de Antioquia

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Annatto-enriched egg; Dietary Supplement: Whole egg; Dietary Supplement: Egg whites - Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05088577

111580763245 (Other Grant/Funding Number)

754-2018

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Whole egg

Experimental group

Description:

Two whole eggs (50g each) to be eaten daily during 8 weeks

Treatment:

Dietary Supplement: Whole egg

Annatto-enriched egg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Annatto-enriched egg

Egg whites - Control

Placebo Comparator group

Description:

Two egg whites to be eaten daily during 8 weeks

Treatment:

Dietary Supplement: Egg whites - Control