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PEANUTS Pilot


- candidate number23736
- NTR NumberNTR5655
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2016
- Secondary IDs15/34 METC Wageningen University
- Public TitlePEANUTS Pilot
- Scientific TitlePeanut protein detection in serum
- ACRONYMPEANUTS Pilot
- hypothesisIn order to support allergy research, well-defined and validated methods for measuring allergens are needed. Currently, there is no such method sensitive enough to detect Ara h6 in the circulation after peanut consumption. Therefore, developing this method would be a valuable tool in the field of food allergies.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers, Food allergy
- Inclusion criteria- 20-35 year old males and females
- Body mass index (BMI) 18.5-25 k- Suitable veins for blood sampling
- Exclusion criteria- History of peanut allergy
- Known symptoms of immune disease, such as diabetes, gastritis, and coeliac disease.
- Known symptoms of intestinal disease, such as Crohn’s Disease, ulcerative colitis, and irritable bowel syndrome.
- Smoking
- Use of hard drugs
- Use of specific medicines:
- Chronic use of NSAIDs: aspirins, ibuprofen, etc.
- Drugs having an effect on gastric and/or intestinal function and motility, including antidepressants.
- Participation in other scientific studies
- Blood donation during the last six weeks before the start of the study
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 5-feb-2016
- planned closingdate12-feb-2016
- Target number of participants10
- InterventionsIntake of 100grams of roasted peanuts.
Blood sampling via venflon cannula at baseline and 30, 60, 120, 240, and 360 min after peanut intake.
- Primary outcomeThe main study outcome is the number of subjects in which Ara h6 can be detected in serum over time following peanut consumption with a sandwich ELISA.
- Secondary outcomeThe secondary outcome is sensitivity of the sandwich ELISA after further optimization
- TimepointsAra h6 will be analysed in serum sampled at baseline and 30, 60, 120, 240, and 360 min after peanut intake.
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Lonneke Janssen Duijghuijsen
- CONTACT for SCIENTIFIC QUERIESDr. Klaske van Norren
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Wageningen University, Wageningen Center for Food Sciences
- Publications
- Brief summaryIn this pilot study 10 healthy, normal weight male and female participants will be tested for their serum peanut protein (Ara h6) levels after intake of 100 grams of roasted peanuts. A sandwich ELISA will be developed and optimized to be able to detect Ara h6 in as many participants as possible at low detection levels.
- Main changes (audit trail)
- RECORD4-feb-2016 - 20-mrt-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl