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Cholesterol Absorption Inhibition Study (CASTELL)

1. mai 2017 oppdatert av: Unilever R&D

CASTELL = Cholesterol Absorption Study STErols (LL)

Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply, life-style change to combat modestly elevated plasma cholesterol concentrations. PS are typically formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be formulated in a new innovative type spread. To confirm that the new spread results in a comparable cholesterol absorption inhibition as the reference product a dual isotope cholesterol study is planned, prior to any larger efficacy study.

Primary objective: Cholesterol absorption inhibition (%) calculated from plasma concentration vs. time curves from labeled cholesterol, for the PS or PSE containing products, compared to a control product without PS or PSE.

Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration vs. time curves.

Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18 healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg) formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30 g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a single dose of either Test, Reference or Control (regular light spread) spreads will be consumed together with standard breakfast. At each study period, 50 mg of D7-cholesterol is added to the meal and 30 mg of 13C-cholesterol is injected to measure cholesterol absorption. Before and four times after consumption of each spread, blood samples will be taken at 24 h intervals up to 7 days.

Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS. Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol after 7 days.

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Noord-Holland
      • Amsterdam, Noord-Holland, Nederland
        • Academisch Medisch Centrum, vasculaire geneeskunde

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

20 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  1. Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
  2. Males aged 20 - 65
  3. BMI 20-27 kg∙m-2
  4. LDL-C levels between 3.0 - 5.0 mmol/L, triglycerides < 3.0 mmol/L
  5. Not more than 10 hours per week of strenuous exercise
  6. Ability to give informed consent.
  7. Ability to follow verbal and written instructions.
  8. Non-smoker (tobacco, marijuana).
  9. The ability to attend and to commute to the performance site for each of study day visit and follow-up throughout the study period are required.
  10. Willing to consume a breakfast in the morning of each study day.
  11. Willing to consume margarine on each study occasion.
  12. Having a general practitioner.
  13. No use of medication which interferes with study measurements (as judged by the study physician).
  14. Agreeing to be informed about medically relevant personal test-results after the screening visit by a physician.
  15. Consumption =< 21 alcoholic drinks in a typical week.
  16. No blood donation 1 month prior to pre-study examination or during the study.
  17. Has accessible veins on the forearm as determined by examination at screening.
  18. Not being an employee of Unilever.
  19. No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
  20. No reported participation in night shift work during the study.

    Exclusion Criteria:

  21. Unwilling to refrain from consumption of plant sterol or stanol containing products one week before and during the study..
  22. Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis, to be judged by study physician.
  23. Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hemato¬logical/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/ psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
  24. Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit, including gallstones or biliary diseases.
  25. History of surgery related to the gastro-intestinal tract
  26. On a medically prescribed or weight reduction diet
  27. Recreational (intravenous) drug use.
  28. The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/ week for males
  29. Concomitant medication that may modulate gastro-intestinal secretions and pH (e.g. antacids, proton-pump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists)
  30. Concomitant medication that can alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgesics, adrenergic agents, calcium channel blockers)
  31. Concomitant medication that can alter intestinal transit (e.g. loperamide, chemical/ osmotic/bulk laxatives), or influence satiety/energy intake (e.g. sibutramine, gluco¬corticoids, anabolic steroids)
  32. Intolerance or allergy for test product.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Reference spread

2250 mg PS (as PSE) in spread (30 g)

  • 50 mg labeled D7-cholesterol,
  • 30 mg 3,4-13C-cholesterol, iv dosed at same time.
Single dose (30 gr) of spread, containing 2250 mg PS
Placebo komparator: Placebo spread

regular light margarine (30 g)

  • 50 mg labeled D7-cholesterol,
  • 30 mg 3,4-13C-cholesterol, iv dosed at same time.
Single dose (30 gr) of regular light margarine
Eksperimentell: Test spread

2250 mg PS in innovatively processed spread (30 g)

  • 50 mg labeled D7-cholesterol,
  • 30 mg 3,4-13C-cholesterol, iv dosed at same time.
Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves
Tidsramme: 5 blood samples within one week for each intervention
5 blood samples within one week for each intervention

Sekundære resultatmål

Resultatmål
Tidsramme
PK parameters derived from plasma curves (Cmax, Tmax, cholesterol pool, flux).
Tidsramme: 5 blood samples within one week for each intervention
5 blood samples within one week for each intervention

Samarbeidspartnere og etterforskere

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

Sponsor

Etterforskere

  • Hovedetterforsker: Maud N Vissers, Dr. Ir, Academisch Medisch Centrum, afdeling vasculaire geneeskunde
  • Studieleder: Guus SM Duchateau, Dr, Unilever Research & Development Vlaardingen

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. juni 2010

Primær fullføring (Faktiske)

1. november 2010

Studiet fullført (Faktiske)

1. november 2010

Datoer for studieregistrering

Først innsendt

4. juni 2010

Først innsendt som oppfylte QC-kriteriene

4. juni 2010

Først lagt ut (Anslag)

7. juni 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 09030V

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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