Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

21. März 2016 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

22

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Nahrungsergänzungsmittel: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Nahrungsergänzungsmittel: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Experimental: 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.
Nahrungsergänzungsmittel: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Nahrungsergänzungsmittel: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum concentration of lutein and beta-carotene
Zeitfenster: 15 days
Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
15 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concentration of lutein and beta-carotene in the chylomicron/TLR fraction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 24 hours
Changes in overall metabolic markers from urine 24 hours postprandial
24 hours
Changes in metabolic markers
Zeitfenster: 24 hours
Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial
24 hours
Changes in metabolic markers
Zeitfenster: 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
Zeitfenster: Baseline
Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.
Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Copenhagen

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2015

Primärer Abschluss (Tatsächlich)

1. Dezember 2015

Studienabschluss (Tatsächlich)

1. Dezember 2015

Studienanmeldedaten

Zuerst eingereicht

17. Mai 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2015

Zuerst gepostet (Schätzen)

21. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

22. März 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. März 2016

Zuletzt verifiziert

1. März 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Spinach - Whole leaf (10 mg lutein)

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Burkina Faso

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren