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

9. januar 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Indiana
      • West Lafayette, Indiana, Forenede Stater, 47907
        • Purdue Clinical Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Placebo komparator: Control
Consuming sautéed vegetables and 3g canola oil without eggs
Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Contents of total and individual carotenoids in triglyceride-rich lipoprotein fractions
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2015

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

4. februar 2016

Først indsendt, der opfyldte QC-kriterier

5. februar 2016

Først opslået (Skøn)

10. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1507016290

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Egg consumption

Abonner