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

9 gennaio 2018 aggiornato da: Wayne Campbell, Purdue University
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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Indiana
      • West Lafayette, Indiana, Stati Uniti, 47907
        • Purdue Clinical Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Egg consumption
Consuming sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs
Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs
Comparatore placebo: Control
Consuming sautéed vegetables and 3g canola oil without eggs
Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Contents of total and individual carotenoids in triglyceride-rich lipoprotein fractions
Lasso di tempo: 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)
From hour 0 to hour 10
Vitamin D content in in triglyceride-rich lipoprotein fractions
Lasso di tempo: 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)
From hour 0 to hour 10

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2015

Completamento primario (Effettivo)

1 maggio 2017

Completamento dello studio (Effettivo)

1 agosto 2017

Date di iscrizione allo studio

Primo inviato

4 febbraio 2016

Primo inviato che soddisfa i criteri di controllo qualità

5 febbraio 2016

Primo Inserito (Stima)

10 febbraio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 gennaio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 gennaio 2018

Ultimo verificato

1 gennaio 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1507016290

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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