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

21. mars 2016 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Kosttilskudd: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Kosttilskudd: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Eksperimentell: 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.
Kosttilskudd: Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Kosttilskudd: Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Copenhagen

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2015

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

17. mai 2015

Først innsendt som oppfylte QC-kriteriene

18. mai 2015

Først lagt ut (Anslag)

21. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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