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van CCT (UK)

van CCT (UK)


- candidate number24356
- NTR NumberNTR5854
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2016
- Secondary IDs16/11 METC Wageningen Universiteit NL57339.081.16
- Public TitlePEANUTS Study
- Scientific TitlePeanut protein detection in serum and exercise
- hypothesisWith a recently developed Ara h6 ELISA we would like to show the effect of exercise on circulating Ara h6 after peanut consumption
- Healt Condition(s) or Problem(s) studiedHealthy volunteers, Food allergy
- Inclusion criteria- 20-35 year old males and females
- Body mass index (BMI) 23-27.5 kg/m2
- Suitable veins for blood sampling
- No inhibitory matrix effect in Ara h6 ELISA method
- Able to cycle 1h on ergometer
- Exclusion criteria- History of peanut allergy
- Known symptoms of immune disease, such as diabetes, gastritis, and coeliac disease.
- Pregnant or lactating
- 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:
o Chronic use of NSAIDs: aspirins, ibuprofen, etc.
o 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 and during the study
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate24-jun-2016
- Target number of participants10
- InterventionsIntake of 100grams of roasted peanuts during 2 test days Intake of 5g Lactulose and 1gr L-rhamnose during two test days
Blood sampling via venflon cannula at baseline and 30, 60, 90, 120, and 240 min after peanut intake during two test days.
Cycling on ergometer 1hr 75% Wmax during 1 test day
- Primary outcomeThe main study parameter is the difference in serum Ara h6 levels over time between a resting and an exercise condition
- Secondary outcomeThe secondary endpoint is the level of exercise-induced permeability
Other outcomes: Body weight, height, intestinal integrity-related markers, such as I-FABP
- TimepointsBlood is sampled at baseline and at T=30, 60, 90, 120, and 240min after peanut consumption. Levels of Ara h6 will be analysed in serum samples collected at each of the time points with the sandwich ELISA method. Plasma levels of lactulose and rhamnose will be analysed in plasma samples collected at baseline and T=60min after peanut consumption. I-FABP will be measured in plasma samples collected at baseline and at T=30 and T=60 min after peanut consumption.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Lonneke Janssen Duijghuijsen
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Wageningen University
- Publications
- Brief summaryIn this intervention study 10 healthy participants will ingest 100grams of peanuts and a dual sugar solution during rest (day 1) or with following exercise (day 2, 75%Wmax cycling). A recently developed ELISA method will be used to assess the effect of exercise on circulating levels of Ara h6 after peanut intake and intestinal permeability will be determined.
- Main changes (audit trail)
- RECORD17-mei-2016 - 1-jul-2016

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