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

NCT05088577 | Completed

• 2 other identifiers: 754-2018111580763245
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Egg; Bixa orellana; Annatto; cardiovascular risk factors; clinical trial

Outcome Measures

Primary Outcomes (20)

• Total cholesterol

  Fasting blood total cholesterol in mg/dL

  Change from Baseline Total cholesterol at 8 weeks

• Low-density lipoprotein (LDL) cholesterol

  Fasting blood LDL cholesterol in mg/dL

  Change from Baseline LDL cholesterol at 8 weeks

• Very low-density lipoprotein (VLDL) cholesterol

  Fasting blood VLDL cholesterol in mg/dL

  Change from Baseline VLDL cholesterol at 8 weeks

• Triglycerides

  Fasting blood triglycerides in mg/dL

  Change from Baseline Triglycerides at 8 weeks

• High-density lipoprotein (HLDL) cholesterol

  Fasting blood HLDL cholesterol in mg/dL

  Change from Baseline HDL cholesterol at 8 weeks

• Glucose

  Fasting blood glucose in mg/dL

  Change from Baseline Glucose at 8 weeks

• Systolic Blood Pressure

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

  Change from Baseline Systolic Blood Pressure at 8 weeks

• Diastolic Blood Pressure

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

  Change from Baseline Diastolic Blood Pressure at 8 weeks

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

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

  Change from Baseline BMI at 8 weeks

• Waist circumference

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

  Change from Baseline Waist circumference at 8 weeks

• Blood lutein levels

  Fasting blood lutein levels in micrograms per mL

  Change from Baseline Blood lutein levels at 8 weeks

• Dietary lutein+zeaxanthin levels

  Dietary lutein+zeaxanthin levels in micrograms

  Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks

• Blood bixin levels

  Fasting blood bixin levels in %

  Change from Baseline Blood bixin levels at 8 weeks

• Triglyceride-Rich lipoprotein (TRLP) size

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

  Change from Baseline TRLP size at 8 weeks

• Low-density lipoprotein (LDL) size

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

  Change from Baseline LDL size at 8 weeks

• High-density lipoprotein (HDL) size

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

  Change from Baseline HDL size at 8 weeks

• Apolipoprotein B (ApoB)

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

  Change from Baseline ApoB at 8 weeks

• Apolipoprotein A1 (ApoA1)

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

  Change from Baseline ApoA1 at 8 weeks

• Ghrelin

  Ghrelin in pg/mL

  Change from Baseline Ghrelin at 8 weeks

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

  "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.

  Change from Baseline VAS of Hunger and Satiety at 8 weeks

Secondary Outcomes (1)

• Ancestry Informative Marker

  Baseline

Study Arms (3)

Whole egg

EXPERIMENTAL

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

Dietary Supplement: Whole egg

Annatto-enriched egg

EXPERIMENTAL

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.

Dietary Supplement: Annatto-enriched egg

Egg whites - Control

PLACEBO COMPARATOR

Two egg whites to be eaten daily during 8 weeks

Dietary Supplement: Egg whites - Control

Interventions

Whole egg DIETARY_SUPPLEMENT

Daily consumption of two whole eggs during 8 weeks

Whole egg

Annatto-enriched egg DIETARY_SUPPLEMENT

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

Annatto-enriched egg

Egg whites - Control DIETARY_SUPPLEMENT

Daily consumption of two eggs whites during 8 weeks

Egg whites - Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (1)

Sede de Investigación Universitaria - Universidad de Antioquia

Medellín, Antioquia, Colombia

Location

Study Officials

• Jacqueline Barona-Acevedo, PhD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 22, 2021
• Study Start: October 11, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

CO (1)