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Healthy VolunteersPhase 4NCT01649492

In Vivo Inhibition Profile of CYP2C9 by Pineapple Juice

A Phase 4 study testing pineapple juice (Carrefour n°1) 500 ml/day 5 days in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The goal of this study is to evaluate the actual potential for in vivo pineapple juice inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of CYP2C9 activity. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
pineapple juice (Carrefour n°1) 500 ml/day 5 days
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBelgium
Study dates
Sep 2012to Oct 2012
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • adult healthy volunteers

Who cannot join

  • younger than 18 yrs
  • older than 60 yrs
  • pregnant or lactating women
  • medical history of gastric or duodenal ulcers, gastro-oesofageal reflux disease, dyspepsia, asthma, any allergy to NSAIDS
  • patients taking co-medication

Trial locations and contacts

1 site in 1 country.

Isabel Spriet, PharmD PhD contact

0032 16 34 30 80

isabel.spriet@uzleuven.be

Pieter Annaert, PharmD PhD contact

0032 16 33 03 03

pieter.annaert@pharm.kuleuven.be

Belgium1 site
  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

The goal of this study is to evaluate the actual potential for in vivo pineapple juice inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of CYP2C9 activity.

Read the detailed description

For ovarian cancer, colorectal and gastric cancers presenting with peritoneal metastases, complete tumor removal at surgery is the most important independent prognostic factor. Consequently, accurate detection of tumors often compromising resectability, like extra-abdominal metastases, liver metastases, portal and superior mesenteric artery deposits and extensive intestinal serosal invasion is pivotal prior to treatment selection. Computed tomography (CT) has variable accuracy for staging, due to the difficult detection of low-contrast or small-sized peritoneal or nodal metastases. Fluorodeoxyglucose positron emission tomography/CT (FDG-PET/CT) improves detection of thoraco-abdominal lymphadenopathy and liver metastases, but inconsistently detects small (<5mm) peritoneal metastases. Therefore a diagnostic staging laparoscopy under general anesthesia is currently the necessary standard of clinical practice in addition to imaging for assessment of operability.

Whole body diffusion-weighted magnetic resonance imaging is researched at the department of radiology, University Hospitals Leuven in collaboration with the departments of abdominal surgery, oncologic surgery, oncologic gynaecology and digestive oncology. The technique holds high promise to combine a high accuracy in systemic thoraco-abdominal staging and peritoneal assessment of operability. Technological progress has enabled time-efficient WB-DWI with thin-slice-acquisition and multiplanar image reformatting. DWI depicts lesions by measuring water diffusion differences, correlating with cellular density. Tumors are depicted with high signal compared to background by combining a short-T1-inversion-time inversion recovery (STIR) prepulse - suppressing ascites, blood vessels, fat, bowel and visceral organs - and heavy diffusion weighting. However, due to contraction and mucosal cellularity, the bowel wall can show increased signal-intensity (SI), hampering the detection of serosal deposits. This is overcome by suppressing contractions by intravenous antispasmodic and by distending the bowel wall and suppressing the signal of bowel content by peroral pineapple juice which shows negative contrast properties due to the manganese-content. In a first pilot study in ovarian cancer at this center in 32 patients, an accuracy for detection of intestinal serosal metastases of 90% was reached by WB-DWI combined with peroral pineapple juice. As such, the pineapple juice plays a pivotal role as a peroral contrast in addition to WB-DWI for accurate peritoneal staging.

To date, the inhibitory potential of pineapple juice on cytochrome P450 2C9 activity has only been described in vitro in human microsomes. In this model, in which diclofenac and its metabolite 4-OH-diclofenac have been used as probes for CYP2C9 activity, it has been shown that pineapple juice is capable to inhibit CYP2C9 very potently (IC50 0.08%) in an irreversible manner. It has been suggested that the main effect is caused by bromelain, a 24-26 kDa cysteine protease enzyme present in pineapple juice. The intestinal absorption of intact bromelain after oral intake has been described in 19 healthy men, which is surprising as the adult intestinal epithelium has traditionally been described as non-permeable to proteins. The (limited) absorption is thought to occur via the paracellular route, which could explain that the catalytic activity bromelain is preserved following absorption into the blood circulation. Although no effects of bromelain on CYP2C9 activity are expected in vivo (due to low oral bioavailability), no in vivo trials have been undertaken to elucidate if pineapple juice, and more specifically bromelain, is capable of inhibiting intestinal and, more importantly, hepatic CYP2C9 in a clinically relevant manner.

The in vivo inhibitory profile of CYP2C9 by pineapple juice will be evaluated in this study in 10 healthy volunteers, by examining the impact on the area-under-the-curves (AUCs) of diclofenac and its metabolite 4-OH diclofenac.

Being tested
pineapple juice (Carrefour n°1) 500 ml/day 5 days
Keywords
diclofenac, CYP2C9, bromelain, pineapple juice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pineapple juice (Carrefour n°1) 500 ml/day 5 daysDietary supplement

Study groups in NCT01649492
Study groupRoleWhat they receive
diclofenac without pineapple juiceNo interventionsingle dose of diclofenac 25 mg without pre-exposure to pineapple juice
diclofenac with pineapple juiceActive comparatorsingle dose of diclofenac 25 mg with pre-exposure to pineapple juice
Receives: Dietary Supplement: pineapple juice (Carrefour n°1) 500 ml/day 5 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a) AUC 4-OH-diclofenac / AUC diclofenac quantified in plasma, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)

    see above

    Measured: day 1 and day 11

Secondary outcomes (1)
  1. (b) AUC 4-OH-diclofenac/ AUC diclofenac quantified in urine, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)

    see above

    Measured: day 1 and day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2012 (estimated)
  4. Study completionOct 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649492
Sponsor's protocol ID
S54465
Status last verified
Jul 2012
First submitted
20 Jul 2012
Last updated
25 Jul 2012
Results posted
No
Data monitoring committee
No

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