- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01138787
Cholesterol Absorption Inhibition Study (CASTELL)
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Noord-Holland
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Amsterdam, Noord-Holland, Alankomaat
- Academisch Medisch Centrum, vasculaire geneeskunde
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
- Males aged 20 - 65
- BMI 20-27 kg∙m-2
- LDL-C levels between 3.0 - 5.0 mmol/L, triglycerides < 3.0 mmol/L
- Not more than 10 hours per week of strenuous exercise
- Ability to give informed consent.
- Ability to follow verbal and written instructions.
- Non-smoker (tobacco, marijuana).
- 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.
- Willing to consume a breakfast in the morning of each study day.
- Willing to consume margarine on each study occasion.
- Having a general practitioner.
- No use of medication which interferes with study measurements (as judged by the study physician).
- Agreeing to be informed about medically relevant personal test-results after the screening visit by a physician.
- Consumption =< 21 alcoholic drinks in a typical week.
- No blood donation 1 month prior to pre-study examination or during the study.
- Has accessible veins on the forearm as determined by examination at screening.
- Not being an employee of Unilever.
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
No reported participation in night shift work during the study.
Exclusion Criteria:
- Unwilling to refrain from consumption of plant sterol or stanol containing products one week before and during the study..
- Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis, to be judged by study physician.
- 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.
- Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit, including gallstones or biliary diseases.
- History of surgery related to the gastro-intestinal tract
- On a medically prescribed or weight reduction diet
- Recreational (intravenous) drug use.
- The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/ week for males
- Concomitant medication that may modulate gastro-intestinal secretions and pH (e.g. antacids, proton-pump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists)
- Concomitant medication that can alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgesics, adrenergic agents, calcium channel blockers)
- 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)
- Intolerance or allergy for test product.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: Reference spread
2250 mg PS (as PSE) in spread (30 g)
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Single dose (30 gr) of spread, containing 2250 mg PS
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Placebo Comparator: Placebo spread
regular light margarine (30 g)
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Single dose (30 gr) of regular light margarine
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Kokeellinen: Test spread
2250 mg PS in innovatively processed spread (30 g)
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Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves
Aikaikkuna: 5 blood samples within one week for each intervention
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5 blood samples within one week for each intervention
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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PK parameters derived from plasma curves (Cmax, Tmax, cholesterol pool, flux).
Aikaikkuna: 5 blood samples within one week for each intervention
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5 blood samples within one week for each intervention
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Maud N Vissers, Dr. Ir, Academisch Medisch Centrum, afdeling vasculaire geneeskunde
- Opintojohtaja: Guus SM Duchateau, Dr, Unilever Research & Development Vlaardingen
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- 09030V
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