Healthy VolunteersEGGANTNCT05088577
Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults
A study testing Whole egg and Annatto-enriched egg in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Whole egg and Annatto-enriched egg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteColombia
- Study dates
- 11 Oct 2019to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Colombia1 site
Sede de Investigación Universitaria - Universidad de Antioquia
Medellín, Antioquia
About this study
Official title: Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in 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.
- Conditions
- Healthy Volunteers
- Being tested
- Whole egg, Annatto-enriched egg, Egg whites - Control
- Keywords
- Egg, Bixa orellana, Annatto, cardiovascular risk factors, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole eggDietary supplement
Daily consumption of two whole eggs during 8 weeks
Annatto-enriched eggDietary supplement
Daily consumption of two whole eggs enriched with annatto during 8 weeks
Egg whites - ControlDietary supplement
Daily consumption of two eggs whites during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole egg | Experimental | Two whole eggs (50g each) to be eaten daily during 8 weeks Receives: 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. Receives: Dietary Supplement: Annatto-enriched egg |
| Egg whites - Control | Placebo comparator | Two egg whites to be eaten daily during 8 weeks Receives: Dietary Supplement: Egg whites - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Fasting blood total cholesterol in mg/dL
Measured: Change from Baseline Total cholesterol at 8 weeks
Low-density lipoprotein (LDL) cholesterol
Fasting blood LDL cholesterol in mg/dL
Measured: Change from Baseline LDL cholesterol at 8 weeks
Very low-density lipoprotein (VLDL) cholesterol
Fasting blood VLDL cholesterol in mg/dL
Measured: Change from Baseline VLDL cholesterol at 8 weeks
Triglycerides
Fasting blood triglycerides in mg/dL
Measured: Change from Baseline Triglycerides at 8 weeks
High-density lipoprotein (HLDL) cholesterol
Fasting blood HLDL cholesterol in mg/dL
Measured: Change from Baseline HDL cholesterol at 8 weeks
Glucose
Fasting blood glucose in mg/dL
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline BMI at 8 weeks
Waist circumference
Waist circumference in centimeters measured at the superior border of the iliac crest
Measured: Change from Baseline Waist circumference at 8 weeks
Blood lutein levels
Fasting blood lutein levels in micrograms per mL
Measured: Change from Baseline Blood lutein levels at 8 weeks
Dietary lutein+zeaxanthin levels
Dietary lutein+zeaxanthin levels in micrograms
Measured: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Blood bixin levels
Fasting blood bixin levels in %
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline HDL size at 8 weeks
Apolipoprotein B (ApoB)
Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance
Measured: Change from Baseline ApoB at 8 weeks
Apolipoprotein A1 (ApoA1)
Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance
Measured: Change from Baseline ApoA1 at 8 weeks
Ghrelin
Ghrelin in pg/mL
Measured: 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.
Measured: Change from Baseline VAS of Hunger and Satiety at 8 weeks
Secondary outcomes (1)
Ancestry Informative Marker
Percentage of genetic ethnicity of European, Amerindian and African for each participant
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start11 Oct 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, Jacqueline Barona Acevedo, Universidad de Antioquia
- Investigators
- Jacqueline Barona-Acevedo, PhD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088577
- Sponsor's protocol ID
- 754-2018
- Other IDs
- 111580763245
- Acronym
- EGGANT
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in Adults.
- ClinicalTrials.gov ID
- NCT05088577
- Acronym / sponsor ID
- EGGANT / 754-2018
- Conditions
- Healthy Volunteers
- Keywords
- Egg, Bixa orellana, Annatto, cardiovascular risk factors, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole egg | Experimental | Dietary Supplement: Whole eggTwo whole eggs (50g each) to be eaten daily during 8 weeks |
| Annatto-enriched egg | Experimental | Dietary Supplement: Annatto-enriched eggTwo 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. |
| Egg whites - Control | Placebo comparator | Dietary Supplement: Egg whites - ControlTwo egg whites to be eaten daily during 8 weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole eggDaily consumption of two whole eggs during 8 weeks | Dietary supplement | Whole egg |
| Annatto-enriched eggDaily consumption of two whole eggs enriched with annatto during 8 weeks | Dietary supplement | Annatto-enriched egg |
| Egg whites - ControlDaily consumption of two eggs whites during 8 weeks | Dietary supplement | Egg whites - Control |
Primary outcome
Total cholesterol
Time frame: Change from Baseline Total cholesterol at 8 weeks
Fasting blood total cholesterol in mg/dL
Low-density lipoprotein (LDL) cholesterol
Time frame: Change from Baseline LDL cholesterol at 8 weeks
Fasting blood LDL cholesterol in mg/dL
Very low-density lipoprotein (VLDL) cholesterol
Time frame: Change from Baseline VLDL cholesterol at 8 weeks
Fasting blood VLDL cholesterol in mg/dL
Triglycerides
Time frame: Change from Baseline Triglycerides at 8 weeks
Fasting blood triglycerides in mg/dL
High-density lipoprotein (HLDL) cholesterol
Time frame: Change from Baseline HDL cholesterol at 8 weeks
Fasting blood HLDL cholesterol in mg/dL
Glucose
Time frame: Change from Baseline Glucose at 8 weeks
Fasting blood glucose in mg/dL
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
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
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
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
Blood lutein levels
Time frame: Change from Baseline Blood lutein levels at 8 weeks
Fasting blood lutein levels in micrograms per mL
Dietary lutein+zeaxanthin levels
Time frame: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Dietary lutein+zeaxanthin levels in micrograms
Blood bixin levels
Time frame: Change from Baseline Blood bixin levels at 8 weeks
Fasting blood bixin levels in %
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
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
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
Apolipoprotein B (ApoB)
Time frame: Change from Baseline ApoB at 8 weeks
Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance
Apolipoprotein A1 (ApoA1)
Time frame: Change from Baseline ApoA1 at 8 weeks
Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance
Ghrelin
Time frame: Change from Baseline Ghrelin at 8 weeks
Ghrelin in pg/mL
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.
1 secondary outcome
Ancestry Informative Marker
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Barona-Acevedo, PhD principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole egg and Annatto-enriched egg in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: Change from Baseline Total cholesterol at 8 weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.