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

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ClinicalTrials.gov Identifier: NCT02679794
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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.

Condition or disease Intervention/treatment Phase
Menopause Behavioral: Egg consumption Behavioral: Control Not Applicable

Detailed Description:

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily. However, US adults only consume on average 2.6 cups of fruits and vegetables daily. This low consumption may further result in the limited availability of fat soluble, health-promoting, phytochemicals such as carotenoids (CAT) from these foods. Dietary CAT have beneficial biological properties including antioxidant and anti-inflammatory effects and scientific research supports the protective effects of CAT against many degenerative diseases, including cardiovascular diseases, age-related macular degeneration, and some types of cancer. Therefore, either low intake or inefficient bioavailability of CAT from fruits and vegetables may reduce their potential effectiveness to retard or prevent disease. Recently completed randomized and crossover study found that co-consuming 150g (3 eggs) of scrambled whole eggs (SWE) which contains18g of lipid, increases overall CAT absorption from a mixed-vegetable salad >7-fold compared to a the same salad without eggs (3g of co-consumed lipid) in young healthy men. However, the occurrence of this benefit in women and older adults is unknown. Aging may affect CAT bioavailability due to age-induced physiological changes including reduced gastrointestinal tract function and modifications of chylomicron metabolism. Eggs are known to be a highly bioavailable source of CAT, presumably due to the presence of lipid and phospholipid in egg yolk. The highly bioavailable nature of CAT from eggs suggest that egg-derived factors may be leveraged to improve bioavailability of other CAT found in co-consumed vegetables. While promising, very limited data exist on the impact of a co-consumed food source of lipid to enhance CAT absorption in women or in older adults.

Vitamin D (VIT D) insufficiency is widespread with nearly 2/3 of Americans not meeting the current Institute of Medicine (IOM) recommendation for serum 25-hydroxyvitamin D (25(OH)D) concentration. VIT D has an essential function to regulate calcium homeostasis, including stimulating calcium's active intestinal absorption and renal excretion. Thus, maintaining adequate VIT D status is critical for overall skeletal health and the prevention of osteoporosis. Post-menopausal women are at high risk of having osteoporosis and this risk is reduced when adequate VIT D status is maintained. VIT D is fat-soluble and only a limited number of foods naturally contain it. Also, while VIT D absorption is enhanced by dietary lipid, the optimal amount of lipid required for maximal absorption has not been determined. A paucity of data exists regarding the effect of a co-consumed food source of lipid to enhance VIT D absorption and the impact of aging on VIT D bioavailability in women.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Impact of Egg Consumption on Carotenoid and Vitamin D Bioavailability in Pre- and Post-menopausal Women
Actual Study Start Date : December 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause Vitamin D

Arm Intervention/treatment
Experimental: Egg consumption
Consuming sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs
Behavioral: Egg consumption
Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs

Placebo Comparator: Control
Consuming sautéed vegetables and 3g canola oil without eggs
Behavioral: Control
Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil.




Primary Outcome Measures :
  1. Contents of total and individual carotenoids in triglyceride-rich lipoprotein fractions [ Time Frame: From hour 0 to hour 10 ]
    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)

  2. Vitamin D content in in triglyceride-rich lipoprotein fractions [ Time Frame: From hour 0 to hour 10 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679794


Locations
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United States, Indiana
Purdue Clinical Research Center
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
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Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT02679794    
Other Study ID Numbers: 1507016290
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018