Will Consuming Eggs With a Mixed Vegetable Salad Increase Carotenoid AbsorptionNCT01951313
Effects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food
A study testing Egg consumption in people with Will Consuming Eggs With a Mixed Vegetable Salad Increase Carotenoid Absorption, run by Purdue University at 1 site in United States.
Trial summary
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Will Consuming Eggs With a Mixed Vegetable Salad Increase Carotenoid Absorption
- What is being tested?
- Egg consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male 19 to 45y BMI 18.5-29.9kg/m2 generally healthy non-smoker
Who cannot join
- Female deep vein thrombosis intestinal disorders fasting blood glucose >110mg/dL smoking drinking more than 3 alcoholic drinks per day taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EffectEffects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health beneficial properties and are known to fight against disease. Eggs are known to be a good source of carotenoids and eggs may improve the absorption of carotenoids found in co-consumed fruits and vegetables. Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will increase carotenoid absorption.
Read the detailed description
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily. However, average fruit and vegetable intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables may further result in the limited availability of fat soluble, health-promoting, phytochemicals such as carotenoids from these foods. Dietary carotenoids have beneficial biological properties including antioxidant and anti-inflammatory effects and scientific research supports the protective effects of carotenoids against many degenerative diseases, including cardiovascular diseases, age-related macular degeneration, and some types of cancer. Therefore, either low intake or inefficient bioavailability of carotenoids from fruits and vegetables may reduce their potential effectiveness as disease preventative compounds. The bioavailability of carotenoids from a meal can be affected by several factors, including food matrix, type of food processing or cooking, interactions with other dietary compounds during digestion and absorption, gut status which may affect digestion and absorption processes, and nutritional status. Co-consumption of carotenoid rich foods with dietary lipids may be one of the most effective stimulators of carotenoid absorption among factors that influence their bioaccessibility and bioavailability. Eggs are known to be a highly bioavailable source of carotenoids, presumably due to the presence of lipid and phospholipid in egg yolk. The highly bioavailable nature of carotenoids from eggs suggest that egg derived factors may be leveraged to improve bioavailability of other carotenoids found in co-consumed fruits and vegetables. While promising, very limited data exist on the impact of a co-consumed food source of lipid, such as eggs, to enhance carotenoid absorption. This study is designed to assess the beneficial effects of egg consumption on carotenoids absorption from a complex meal, beyond those found in egg.
- Being tested
- Egg consumption
- Keywords
- Meal tolerance test focusing on carotenoids absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg consumptionOther
Subjects will participate in 3 testing days (randomized, crossover design). Each day, the subject will consume a carefully portioned mix-vegetable salad without eggs (C, control); 75g (about 1½ eggs) scrambled whole egg (LE, low egg), and 150g (about 3 eggs) scrambled whole egg (HE, high egg). Prior to each testing day, subjects will consume a low-carotenoid diet for 7 days to reduce blood carotenoid concentration. In the testing day, blood collected every 60 minutes for 10 hours will be processed to analyze carotenoid and vitamin E concentrations. At the 5-h time point, subjects will be fed a low fat (< 2g) and low carotenoid (< 2000µg) meal as the 2nd meal.
| Study group | Role | What they receive |
|---|---|---|
| Egg consumption | Experimental | No egg 75g of scrambled eggs 150g of scrambled eggs Receives: Other: Egg consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotenoids absorption
Carotenoids absorption Area under the curve of carotenoids such as lutein, zeaxanthin, α-carotene, α-cryptoxanthin, β-cryptoxanthin, β-carotene, and lycopene and vitamin E in plasma triacylglycerol rich lipoproteins fractions
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Will Consuming Eggs With a Mixed Vegetable Salad Increase Carotenoid AbsorptionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951313
- Sponsor's protocol ID
- 1308013929
- Status last verified
- Jun 2014
- First submitted
- 12 Sep 2013
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JE, Ferruzzi MG, Campbell WW. Egg Consumption Increases Vitamin E Absorption from Co-Consumed Raw Mixed Vegetables in Healthy Young Men. J Nutr. 2016 Nov;146(11):2199-2205. doi: 10.3945/jn.116.236307. Epub 2016 Sep 21.
PubMed 27655756Kim JE, Gordon SL, Ferruzzi MG, Campbell WW. Effects of egg consumption on carotenoid absorption from co-consumed, raw vegetables. Am J Clin Nutr. 2015 Jul;102(1):75-83. doi: 10.3945/ajcn.115.111062. Epub 2015 May 27.
PubMed 26016861
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EffectEffects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food
- ClinicalTrials.gov ID
- NCT01951313
- Acronym / sponsor ID
- 1308013929
- Keywords
- Meal tolerance test focusing on carotenoids absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Sep 2013 (estimated)
- 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.
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health beneficial properties and are known to fight against disease. Eggs are known to be a good source of carotenoids and eggs may improve the absorption of carotenoids found in co-consumed fruits and vegetables. Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will increase carotenoid absorption.
Detailed description
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily. However, average fruit and vegetable intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables may further result in the limited availability of fat soluble, health-promoting, phytochemicals such as carotenoids from these foods. Dietary carotenoids have beneficial biological properties including antioxidant and anti-inflammatory effects and scientific research supports the protective effects of carotenoids against many degenerative diseases, including cardiovascular diseases, age-related macular degeneration, and some types of cancer. Therefore, either low intake or inefficient bioavailability of carotenoids from fruits and vegetables may reduce their potential effectiveness as disease preventative compounds. The bioavailability of carotenoids from a meal can be affected by several factors, including food matrix, type of food processing or cooking, interactions with other dietary compounds during digestion and absorption, gut status which may affect digestion and absorption processes, and nutritional status. Co-consumption of carotenoid rich foods with dietary lipids may be one of the most effective stimulators of carotenoid absorption among factors that influence their bioaccessibility and bioavailability. Eggs are known to be a highly bioavailable source of carotenoids, presumably due to the presence of lipid and phospholipid in egg yolk. The highly bioavailable nature of carotenoids from eggs suggest that egg derived factors may be leveraged to improve bioavailability of other carotenoids found in co-consumed fruits and vegetables. While promising, very limited data exist on the impact of a co-consumed food source of lipid, such as eggs, to enhance carotenoid absorption. This study is designed to assess the beneficial effects of egg consumption on carotenoids absorption from a complex meal, beyond those found in egg.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egg consumption | Experimental | Other: Egg consumptionNo egg 75g of scrambled eggs 150g of scrambled eggs |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male 19 to 45y BMI 18.5-29.9kg/m2 generally healthy non-smoker
Key exclusion criteria (1 listed)
- Female deep vein thrombosis intestinal disorders fasting blood glucose >110mg/dL smoking drinking more than 3 alcoholic drinks per day taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
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 |
|---|---|---|
| Egg consumptionSubjects will participate in 3 testing days (randomized, crossover design). Each day, the subject will consume a carefully portioned mix-vegetable salad without eggs (C, control); 75g (about 1½ eggs) scrambled whole egg (LE, low egg), and 150g (about 3 eggs) scrambled whole egg (HE, high egg). Prior to each testing day, subjects will consume a low-carotenoid diet for 7 days to reduce blood carotenoid concentration. In the testing day, blood collected every 60 minutes for 10 hours will be processed to analyze carotenoid and vitamin E concentrations. At the 5-h time point, subjects will be fed a low fat (< 2g) and low carotenoid (< 2000µg) meal as the 2nd meal. | Other | Egg consumption |
Primary outcome
Carotenoids absorption
Time frame: 6-8 weeks
Carotenoids absorption Area under the curve of carotenoids such as lutein, zeaxanthin, α-carotene, α-cryptoxanthin, β-cryptoxanthin, β-carotene, and lycopene and vitamin E in plasma triacylglycerol rich lipoproteins fractions
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 18 Jun 2014.
- Derived from this study: PubMed 27655756Kim JE, Ferruzzi MG, Campbell WW. Egg Consumption Increases Vitamin E Absorption from Co-Consumed Raw Mixed Vegetables in Healthy Young Men. J Nutr. 2016 Nov;146(11):2199-2205. doi: 10.3945/jn.116.236307. Epub 2016 Sep 21.
- Derived from this study: PubMed 26016861Kim JE, Gordon SL, Ferruzzi MG, Campbell WW. Effects of egg consumption on carotenoid absorption from co-consumed, raw vegetables. Am J Clin Nutr. 2015 Jul;102(1):75-83. doi: 10.3945/ajcn.115.111062. Epub 2015 May 27.
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.
Wayne W Campbell, Ph.D principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg consumption in people with Will Consuming Eggs With a Mixed Vegetable Salad Increase Carotenoid Absorption, run by Purdue University at 1 site in United States.
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 1 inclusion and 1 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 18 Jun 2014. 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 United States. 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. 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?
Carotenoids absorption (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01951313, which also lists 2 linked publications.
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 18 Jun 2014.