An interventional study of Air Structuring Protein and Placebo sorbet in Allergy to Mold, sponsored by Unilever SEAC. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Unilever SEAC · Not applicable and Interventional
Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.
Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.
As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:
The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.
In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.
This is a multi centre study which is taking place in the UK.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 252 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →This is the only study on the registry with Unilever SEAC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Placebo sorbet
Other: Air Structuring Protein
Other: Air Structuring Protein
A novel food protein preparation
Placebo sorbet for double blind placebo controlled food challenge
Positive skin prick test response to test material
The number and size of positive SPTs will be recorded together with data of concomitant allergies and the minimum eliciting concentration (SPT-min) in the skin.
Time frame: 15 minutes after application
The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result
The number of positive DBPCFC reactions will be recorded together with pre and post challenge blood pressure, pulse rate, peak expiratory flow (PEF) and forced expiratory volume (FEV1), data of concomitant allergies, any symptoms elicited including any late onset reactions, timing of symptoms and the minimum eliciting dose of ASP.
Time frame: 2 hours after administration
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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