Impact of Egg Consumption on Carotenoid and Vitamin D Bioavailability in Pre- and Post-menopausal Women

NCT02679794 | Completed

• 1 other identifier: 1507016290
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in a limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health-promoting properties and are known to fight against disease. Although, maintaining adequate vitamin D status is critical for overall skeletal health and the prevention of osteoporosis, vitamin D insufficiency is also widespread in the United States. Eggs, egg yolk in particular, are known to be a good source of lipid and may improve the absorption of carotenoids and vitamin D found in co-consumed vegetables in young and older women. Therefore, the investigators are interested to see if consuming eggs with cooked vegetables will increase carotenoids and vitamin D absorption.

Conditions

Menopause

Outcome Measures

Primary Outcomes (2)

• Contents of total and individual carotenoids in triglyceride-rich lipoprotein fractions

  composite 0-10 h area under the curve of total and individual carotenoids (lutein, zeaxanthin, alpha-carotene, beta-carotene, lycopene) in triglyceride-rich lipoprotein fractions (all units are nmol/L x 10 hours)

  From hour 0 to hour 10

• Vitamin D content in in triglyceride-rich lipoprotein fractions

  composite 0-10 h area under the curve of vitamin D2, vitamin D3, 25(OH)D2, and 25(OH)D3 in triglyceride-rich lipoprotein fractions (all units are nmol/L x 10 hours)

  From hour 0 to hour 10

Study Arms (2)

Egg consumption

EXPERIMENTAL

Consuming sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs

Behavioral: Egg consumption

Control

PLACEBO COMPARATOR

Consuming sautéed vegetables and 3g canola oil without eggs

Behavioral: Control

Interventions

Egg consumption BEHAVIORAL

Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs

Egg consumption

Control BEHAVIORAL

Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre- (regularly menstruating, aged 19-45y) and post-menopausal (aged 60+y) females
• weight stable (± 3 kg in the past 3 months)
• constant habitual activity patterns within last 3 months
• no acute illness
• not diabetic or have chronic diseases known to influence lipid or energy metabolism
• blood 25(OH)D\>20 nmol/L
• non-smoking
• drinking no more than 2 alcoholic drinks per day
• not taking estrogen-based birth control or osteoporosis prevention or treatment medications in the past 3 months
• not taking lipid-lowering medications

You may not qualify if:

• Males
• age \<19 or age \>45y for pre-menopausal women and age \<60y for post-menopausal women
• weight change\>3 kg in the past 3 months
• exercising vigorously over the past 3 months
• intestinal disorders including lipid malabsorption or lactose intolerance
• abnormal liver or kidney function tests
• blood 25(OH)D\<20 nmol/L
• fasting blood glucose\>110 mg/dL
• smoking
• drinking more than 2 alcoholic drinks per day
• taking estrogen-based birth control or osteoporosis prevention or treatment medications in the past 3 months
• taking lipid-lowering medications affecting plasma cholesterol concentration

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue Clinical Research Center

West Lafayette, Indiana, 47907, United States

Location

Study Officials

• Wayne W Campbell, Ph.D.

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wayne Campbell, Ph.D.

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 10, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

US (1)