The primary objective is to set-up a well-defined sandwich ELISA method to measure the levels of Ara h6 in blood after peanut consumption.
ID
Source
Brief title
Condition
- Malabsorption conditions
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter of the pilot study is the number of subjects in which Ara
h6 in serum can be detected with the sandwich ELISA after peanut consumption
Secondary outcome
The secundary parameter of this pilot study are serum factors that could
possibly influence the sensitivity of the analysis method, such as total peanut
IgE and IgG(4)
Background summary
Since the exponential increase in the prevalence of food allergies, studies in
this field have also increased exponentially. In order to support this
research, well-defined and validated methods for measuring these 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.
Study objective
The primary objective is to set-up a well-defined sandwich ELISA method to
measure the levels of Ara h6 in blood after peanut consumption.
Study design
Within this pilot study, participants are requested to come to the university
twice. First for a short screening visit (questionnaire and height/weight
measurement). For the test day participants will again come to the university,
while fasted overnight, to consume 100grams of peanuts. Prior to (baseline) and
after intake (30, 60, 120, 240, 360min) of the peanuts, blood will be samples
via a venflon cannula. at the end, the participants will receive lunch.
Intervention
Intake of 100 grams of peanuts
Study burden and risks
Subjects need to fill out a screening questionnaire and height/weight are
measured. The subjectshave to keep some dietary guidlines, such as no peanut
consumption two days prior to test day. Blood withdrawal could lead to minor
bruising and stiffness of the arm, and is minimalized by using a venflon
canula.Per test day, a total of 72mL blood will be sampled at regular intervals
during six hours. Overnight and during these six hours after peanut intake,
subjects are not allowed to eat anything else. Seen the caloric density (Equals
four cheese sandwiches) and satiating effect of the peanuts, this burden will
be small.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
- 20-35 year old males and females
- Body Mass Index (BMI) 18.5-25 kg/m2
- 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, ulcerosis, and irritable bowel syndrome.
- Smoking
- Use of hard drugs
- Use of specific drugs: 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 (with the exception of EetMeetWeet)
- Blood donation during the last six weeks before the start of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55953.081.15 |