NCT01951313

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

September 12, 2013

Last Update Submit

June 17, 2014

Conditions

Keywords

Meal tolerance test focusing on carotenoids absorption

Outcome Measures

Primary Outcomes (1)

  • 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

    6-8 weeks

Study Arms (1)

Egg consumption

EXPERIMENTAL

No egg 75g of scrambled eggs 150g of scrambled eggs

Other: Egg consumption

Interventions

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.

Egg consumption

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male 19 to 45y BMI 18.5-29.9kg/m2 generally healthy non-smoker

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (2)

  • 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.

  • Kim 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.

Study Officials

  • Wayne W Campbell, Ph.D

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 26, 2013

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations