A randomized, double-blinded, placebo-controlled oral challenge study to evaluate the allergenicity of commercial, food-grade fish gelatin

Tine K. Hansen, Lars K. Poulsen, Per Stahl Skov, Susan L. Hefle, Jason J. Hlywka, Stephen L Taylor, Ulla Bindslev-Jensen, Carsten Bindslev-Jensen

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

Background. Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. Objective. To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. Methods. Thirty fish-allergic patients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. Results. In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. Conclusion. None of 30 fish allergic patients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergic patients at the doses typically used. Statistically, these results indicate that there is 95% certainty that 90% of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.

Original languageEnglish (US)
Pages (from-to)2037-2044
Number of pages8
JournalFood and Chemical Toxicology
Volume42
Issue number12
DOIs
StatePublished - Dec 1 2004

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allergenicity
food grades
Gelatin
gelatin
Fish
placebos
mouth
Fishes
Placebos
Food
fish
skin tests
Histamine Release
Skin
histamine
Skin Tests
Histamine
dosage
signs and symptoms (animals and humans)
Immunoglobulin E

Keywords

  • Double-blinded
  • Fish allergy
  • Gelatin
  • Histamine release
  • Placebo-controlled food challenge
  • Skin prick test
  • specific IgE

ASJC Scopus subject areas

  • Food Science
  • Toxicology

Cite this

A randomized, double-blinded, placebo-controlled oral challenge study to evaluate the allergenicity of commercial, food-grade fish gelatin. / Hansen, Tine K.; Poulsen, Lars K.; Stahl Skov, Per; Hefle, Susan L.; Hlywka, Jason J.; Taylor, Stephen L; Bindslev-Jensen, Ulla; Bindslev-Jensen, Carsten.

In: Food and Chemical Toxicology, Vol. 42, No. 12, 01.12.2004, p. 2037-2044.

Research output: Contribution to journalArticle

Hansen, TK, Poulsen, LK, Stahl Skov, P, Hefle, SL, Hlywka, JJ, Taylor, SL, Bindslev-Jensen, U & Bindslev-Jensen, C 2004, 'A randomized, double-blinded, placebo-controlled oral challenge study to evaluate the allergenicity of commercial, food-grade fish gelatin', Food and Chemical Toxicology, vol. 42, no. 12, pp. 2037-2044. https://doi.org/10.1016/j.fct.2004.08.008
Hansen, Tine K. ; Poulsen, Lars K. ; Stahl Skov, Per ; Hefle, Susan L. ; Hlywka, Jason J. ; Taylor, Stephen L ; Bindslev-Jensen, Ulla ; Bindslev-Jensen, Carsten. / A randomized, double-blinded, placebo-controlled oral challenge study to evaluate the allergenicity of commercial, food-grade fish gelatin. In: Food and Chemical Toxicology. 2004 ; Vol. 42, No. 12. pp. 2037-2044.
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abstract = "Background. Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. Objective. To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. Methods. Thirty fish-allergic patients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. Results. In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. Conclusion. None of 30 fish allergic patients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergic patients at the doses typically used. Statistically, these results indicate that there is 95{\%} certainty that 90{\%} of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.",
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AU - Poulsen, Lars K.

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AU - Hefle, Susan L.

AU - Hlywka, Jason J.

AU - Taylor, Stephen L

AU - Bindslev-Jensen, Ulla

AU - Bindslev-Jensen, Carsten

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N2 - Background. Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. Objective. To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. Methods. Thirty fish-allergic patients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. Results. In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. Conclusion. None of 30 fish allergic patients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergic patients at the doses typically used. Statistically, these results indicate that there is 95% certainty that 90% of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.

AB - Background. Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. Objective. To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. Methods. Thirty fish-allergic patients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. Results. In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. Conclusion. None of 30 fish allergic patients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergic patients at the doses typically used. Statistically, these results indicate that there is 95% certainty that 90% of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.

KW - Double-blinded

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KW - Gelatin

KW - Histamine release

KW - Placebo-controlled food challenge

KW - Skin prick test

KW - specific IgE

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