Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices (Popeye)

21 maart 2016 bijgewerkt door: Professor Lars Ove Dragsted, University of Copenhagen

Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.

The study will be conducted as a randomised, controlled, 2-way crossover study in 24 participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation. The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.

The study will be conducted as a randomised, controlled, 2-way crossover study. Twenty four participants (12 in each group) will be randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation (differentiates only on the basis of particle size).

The intervention period is sub-divided into three parts: run-in period (48 hours) with a standardized low-carotenoid diet, 0-24 hours (follow-up period 1 (FP1)) and 24 hours - 2 weeks (FP2). The intervention periods will be separated by a wash-out period of at least 14 days.

At start of each intervention, the intervention meal (breakfast) is served, followed by standardized, carotenoid-free meals in the following 24 hours. Participants will in FP1 and FP2 receive an intervention meal every second day. Participants will otherwise keep their habitual diets during these follow-up periods.

Study participants are asked to collect urine during 24 hours before and after the first intervention meal in each period. They will also collect feces/ileostomy efflux for 24 hours before and after initiation of the intervention for short bowel/ileostomy patients and for 48 periods in the healthy volunteers, respectively. Overnight-fasting serum samples are drawn at day 1, 7 and 15 of each intervention period. On day 1 plasma samples are drawn at 0,1, 3, 4, 6, 7, 9 and 24 hours post first intervention meal.

Plasma and effluent levels of lutein and beta-carotene will be determined and chylomicrons are also separated from these samples for determination of carotenoids.

Volunteers also have their macula examined for density of the yellow spot before and after the intervention. Plasma and effluent levels of other carotenoids as well as fat-soluble vitamins are also determined. The samples will also be subjected to metabolic profiling for further exploration and hypothesis generation.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

22

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Copenhagen Ø, Denemarken, 2100
        • Rigshospitalet, Department of Gastroenterology, CA-2121
      • Frederiksberg C, Denemarken, 1958
        • Department of Nutrition, Exercise and sports, University of Copenhagen

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

List of inclusion criteria:

  • Healthy adults (18-80 years old)
  • Body Mass Index (BMI) between 18,9-28
  • Normal fasting blood glucose (BS) (1,9-5,6 mmol/L)
  • Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

List of exclusion criteria:

  • Intestinal diseases (among healthy controls), systemic infections, psychiatric disorders, metabolic diseases (incl. diabetes), and any clinical condition/circumstance which assessed by the study official makes the person unfit for participation in the trial.
  • Patients diagnosed with short bowel syndrome (SBS).
  • Chronic or frequent use of medication. Primarily consumption of drugs with known effect/side effects on fat absorption. Further, anticoagulants (Marevan) and systemic treatment with glucocorticoids.
  • Have or have had a drug addiction
  • Smokers
  • Alcohol consumption beyond the recommended (7/14 units per week for women/men, respectively)
  • Intake of vitamins or other supplements (3 months before the study and during the study) (healthy controls). Subjects from the patient group included only with stable intake of dietary supplements through the last 3 months.
  • Sampling or donation of larger amount of blood e.g. as blood donors or to other scientific experiments from 3 months before the study until its completion.
  • allergy or intolerance to any of the foods included in the study.
  • Women who are nursing, pregnant or planning pregnancy
  • Not able to comply with the procedures protocol.
  • Macular degeneration to a degree greeter than or equal to a surface area with one or more drusen larger than 125 microns in diameter in at least one eye.
  • Cataracts, macular- or other ocular disease, preventing depiction of xanthophyll pigment.

The following separate registered information was additionally recorded for short bowel/ileostomy patients:

  • Time since operation (stable, >1 year post operation)
  • Type of disease/background for operation
  • Intestinal anatomy (inclusive length and type of residual intestine)
  • Type and doses of vitamin and other types of supplementation

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Spinach - Whole leaf (10 mg lutein)

1-2: Group given whole leaf as first intervention Whole leaf spinach (10 mg lutein) given every second day for a 15 days period.

Followed by:

Minced spinach (10 mg lutein) given every second day for a 15 days period.
Voedingssupplement: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Voedingssupplement: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Experimenteel: Spinach - Minced (10 mg lutein)

2-1: Group given minced spinach as first intervention Minced spinach (10 mg lutein) given every second day for a 15 days period.

Followed by:

Whole leaf spinach (10 mg lutein) given every second day for a 15 days period.
Voedingssupplement: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Voedingssupplement: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serum concentration of lutein and beta-carotene
Tijdsspanne: 15 days
Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
15 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concentration of lutein and beta-carotene in the chylomicron/TLR fraction
Tijdsspanne: 24 hours
Changes in concentration of lutein and beta-carotene in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.
24 hours
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux
Tijdsspanne: 48/24 hours
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively.
48/24 hours
Concentration of other carotenoids in the chylomicron/TLR fraction
Tijdsspanne: 24 hours
Changes in concentration of other carotenoids in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.
24 hours
Serum concentration of other carotenoids
Tijdsspanne: 15 days
Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.
15 days
Serum concentration of other fat-soluble vitamins
Tijdsspanne: 15 days
Difference in serum concentration of other vitamins (A, E; D, K) between baseline and the end of each intervention period.
15 days
Changes in metabolic markers
Tijdsspanne: 24 hours
Changes in overall metabolic markers from urine 24 hours postprandial
24 hours
Changes in metabolic markers
Tijdsspanne: 24 hours
Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial
24 hours
Changes in metabolic markers
Tijdsspanne: 15 days
Changes in overall metabolic markers in serum at the end of each intervention period.
15 days
Level of optical density of the macula lutea
Tijdsspanne: Baseline
Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Copenhagen

Medewerkers

Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
Agroscope Liebefeld-Posieux Research Station ALP
Herta Messerli Stiftung

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2015

Primaire voltooiing (Werkelijk)

1 december 2015

Studie voltooiing (Werkelijk)

1 december 2015

Studieregistratiedata

Eerst ingediend

17 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2015

Eerst geplaatst (Schatting)

21 mei 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

22 maart 2016

Laatste update ingediend die voldeed aan QC-criteria

21 maart 2016

Laatst geverifieerd

1 maart 2016

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • M220
  • H-3-2014-112/46407 (Andere identificatie: The Danish Ethics Committee)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Gezond

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Cameroon

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren