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Completed

NCT Number: NCT05088577

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sede de Investigación Universitaria - Universidad de Antioquia

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole egg

Dietary Supplement

Daily consumption of two whole eggs during 8 weeks

Annatto-enriched egg

Dietary Supplement

Daily consumption of two whole eggs enriched with annatto during 8 weeks

Egg whites - Control

Dietary Supplement

Daily consumption of two eggs whites during 8 weeks

Primary outcomes

  1. Total cholesterol

    Time frame: Change from Baseline Total cholesterol at 8 weeks

    Fasting blood total cholesterol in mg/dL

  2. Low-density lipoprotein (LDL) cholesterol

    Time frame: Change from Baseline LDL cholesterol at 8 weeks

    Fasting blood LDL cholesterol in mg/dL

  3. Very low-density lipoprotein (VLDL) cholesterol

    Time frame: Change from Baseline VLDL cholesterol at 8 weeks

    Fasting blood VLDL cholesterol in mg/dL

  4. Triglycerides

    Time frame: Change from Baseline Triglycerides at 8 weeks

    Fasting blood triglycerides in mg/dL

  5. High-density lipoprotein (HLDL) cholesterol

    Time frame: Change from Baseline HDL cholesterol at 8 weeks

    Fasting blood HLDL cholesterol in mg/dL

  6. Glucose

    Time frame: Change from Baseline Glucose at 8 weeks

    Fasting blood glucose in mg/dL

  7. Systolic Blood Pressure

    Time frame: Change from Baseline Systolic Blood Pressure at 8 weeks

    Systolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 130 mmHg

  8. Diastolic Blood Pressure

    Time frame: Change from Baseline Diastolic Blood Pressure at 8 weeks

    Diastolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 85 mmHg

  9. Body Mass Index (BMI) in kg/m^2: weight in kilograms, height in meters

    Time frame: Change from Baseline BMI at 8 weeks

    weight and height will be combined to report BMI in kg/m^2

  10. Waist circumference

    Time frame: Change from Baseline Waist circumference at 8 weeks

    Waist circumference in centimeters measured at the superior border of the iliac crest

  11. Blood lutein levels

    Time frame: Change from Baseline Blood lutein levels at 8 weeks

    Fasting blood lutein levels in micrograms per mL

  12. Dietary lutein+zeaxanthin levels

    Time frame: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks

    Dietary lutein+zeaxanthin levels in micrograms

  13. Blood bixin levels

    Time frame: Change from Baseline Blood bixin levels at 8 weeks

    Fasting blood bixin levels in %

  14. Triglyceride-Rich lipoprotein (TRLP) size

    Time frame: Change from Baseline TRLP size at 8 weeks

    Fasting blood subclasses (Large, medium, small) of TRLP in nmol/L measured by Nuclear Magnetic Resonance

  15. Low-density lipoprotein (LDL) size

    Time frame: Change from Baseline LDL size at 8 weeks

    Fasting blood subclasses (Large, medium, small) of LDL in nmol/L measured by Nuclear Magnetic Resonance

  16. High-density lipoprotein (HDL) size

    Time frame: Change from Baseline HDL size at 8 weeks

    Fasting blood subclasses (Large, medium, small) of HDL in μmol/L measured by Nuclear Magnetic Resonance

  17. Apolipoprotein B (ApoB)

    Time frame: Change from Baseline ApoB at 8 weeks

    Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance

  18. Apolipoprotein A1 (ApoA1)

    Time frame: Change from Baseline ApoA1 at 8 weeks

    Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance

  19. Ghrelin

    Time frame: Change from Baseline Ghrelin at 8 weeks

    Ghrelin in pg/mL

  20. Visual Analog Scale (VAS) to Measure Perceived Hunger and Satiety

    Time frame: Change from Baseline VAS of Hunger and Satiety at 8 weeks

    "Visual Analog Scale to measure perceived hunger and satiety" to complete in the morning, fasting, 5 days before entering the study and the last 5 days to end the study (8th week). The VAS consist of 8 questions followed each by a line of 10cm in which the person marks a position corresponding to his/her feelings about hunger and satiety. A higher score (10) means the person feels with more hunger or satisfied.

Secondary outcomes

  1. Ancestry Informative Marker

    Time frame: Baseline

    Percentage of genetic ethnicity of European, Amerindian and African for each participant

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Registry information

Official study title

Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in Adults.

Acronym: EGGANT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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