Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

21. marts 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Kosttilskud: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Kosttilskud: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Eksperimentel: 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.
Kosttilskud: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Kosttilskud: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum concentration of lutein and beta-carotene
Tidsramme: 15 days
Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
15 days

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Copenhagen

Samarbejdspartnere

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

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

1. januar 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

17. maj 2015

Først indsendt, der opfyldte QC-kriterier

18. maj 2015

Først opslået (Skøn)

21. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

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

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 Spinach - Whole leaf (10 mg lutein)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Belarus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner