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Sanchez-Perez, SoniaAuthorRuiz-León, Ana MaríaAuthorCasanovas-Garriga, FrancescAuthorFernandez-Sola, JoaquimAuthorMunoz-Cano, Rosa MAuthorBartra, JoanAuthorCasas, RosaCorresponding AuthorEstruch, RamonAuthor

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January 23, 2025
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Article

Study Protocol for a Prospective, Unicentric, Double-Blind, Randomized, and Placebo-Controlled Trial on the Efficacy of a Low-Histamine Diet and DAO Enzyme Supplementation in Patients with Histamine Intolerance

Publicated to: Nutrients. 17 (1): 29- - 2025-01-01 17(1), DOI: 10.3390/nu17010029

Authors:

Duelo, Adriana; Sanchez-Perez, Sonia; Ruiz-Leon, Ana Maria; Casanovas-Garriga, Francesc; Pellicer-Roca, Salvador; Iduriaga-Platero, Irache; Costa-Catala, Judit; Veciana-Nogues, M Teresa; Fernandez-Sola, Joaquim; Munoz-Cano, Rosa M; Bartra, Joan; Combalia, Andrea; Comas-Baste, Oriol; Casas, Rosa; Latorre-Moratalla, M Luz; Estruch, Ramon; Vidal-Carou, M Carmen
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Affiliations

Ctr Invest Biomed Red Fisiopatol Obes & Nutr CIBER, Madrid 28029, Spain - Author
Fdn Dieta Mediterranea, Barcelona 08021, Spain - Author
Inst Invest Biomed August Pi I Sunyer IDIBAPS, Barcelona 08036, Spain - Author
Malalties metabòliques hereditàries i malalties musculars. Institut d'Investigacions Biomèdiques August Pi i Sunyer - Author
RICORS Red Enfermedades Inflamatorias REI, Inst Salud Carlos 3, Madrid 28029, Spain - Author
Univ Barcelona UB, Dept Nutricio Ciencies Alimentacio & Gastron, Campus Alimentacio Torribera, Santa Coloma De Gramenet 08921, Spain - Author
Univ Barcelona UB, Hosp Clin Barcelona, Dept Med Interna, Barcelona 08036, Spain - Author
Univ Barcelona UB, Hosp Clin Barcelona, Dept Pathol, Barcelona 08036, Spain - Author
Univ Barcelona UB, Hosp Clin, Serv Al Lergol, Barcelona 08036, Spain - Author
Univ Barcelona UB, Inst Recerca Nutricio Seguretat Alimentaria INSA U, Santa Coloma De Gramenet 08921, Spain - Author
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Abstract

Background/Objectives: Histamine intolerance is primarily caused by a deficiency in the diamine oxidase (DAO) enzyme at the intestinal level. The reduced histamine degradation in the gut leads to its accumulation in plasma, thereby causing multiple clinical manifestations, such as urticaria, diarrhea, headache, dyspnea, or tachycardia, among others. The dietary management of this food intolerance consists of the follow-up of a low-histamine diet, often combined with DAO supplementation. To date, around twenty studies have investigated the effectiveness of these dietary strategies in reducing the frequency and/or intensity of symptoms, with promising results. However, the limitations of these studies (small patient cohort, lack of control group, and short dietary intervention periods) highlight the need for more ambitiously designed research. Therefore, the main objective of this prospective, unicentric, double-blind, randomized, and placebo-controlled trial is to evaluate the efficacy of a low-histamine diet and/or DAO supplementation over a three-month period in improving symptoms of histamine intolerance. Additionally, the impacts of these dietary strategies on the intestinal microbiota composition, urinary profile of histamine metabolites, serum DAO activity, and plasma histamine levels will be assessed throughout the intervention. Methods: The trial will enroll 400 patients who will be randomly assigned to one of two groups: the intervention group, which will follow a low-histamine diet, or the control group, which will maintain their habitual dietary habits. Within each of these groups, participants will be further divided into four subgroups to receive either exogenous DAO enzyme supplementation (from porcine or plant sources, with the latter administered at two different dosages) or a placebo. Therefore, a total of eight distinct intervention groups will be considered. The comparison of these groups will allow the evaluation of the individual effects of the low-histamine diet or DAO enzyme supplementation, as well as their possible synergistic effect. Results: The results of this study should help to improve dietary recommendations for histamine-intolerant patients and ultimately enhance their quality of life.
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Keywords

AdultAmine oxidase (copper containing)Amine oxidase (copper-containing)ArticleAssaigs clínicsBloodClinical effectivenessClinical trial protocolClinical trialsControlled studyDao deficiencyDietDiet restrictionDietary supplementDietary supplementsDouble blind procedureDouble-blind methodDrug effectDrug-nutrient interactionsElimination dietEnzyme activityEnzyme blood levelEnzyme therapyFeeding behaviorFemaleFollow upFood intoleranceFood supplemenFood supplementGastrointestinal microbiomeHeadacheHistaminaHistamineHistamine blood levelHistamine intoleranceHistamine-related symptomsHistamine-restricted dietHumanHumansIndeInteraccions medicament-nutrientIntestinal microbiotaIntestine floraMajor clinical studyMaleMiddle agedNonhumanNutritional intolerancePlaceboProspective studiesProspective studyQuality of lifeQuality-of-lifeRandomized controlled trialRandomized controlled trial (topic)Randomized controlled trials as topicSubgroupSynergistic effectTreatment durationTreatment outcomeUrinary histamine metabolitesUrine samplingUrticariaValidationYoung adult

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Nutrients due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2025, it was in position 17/113, thus managing to position itself as a Q1 (Primer Cuartil), in the category Nutrition & Dietetics.

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Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2026-04-02:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 26.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 22 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 4.
  • The number of mentions on the social network X (formerly Twitter): 3 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
  • Assignment of a Handle/URN as an identifier within the deposit in the Institutional Repository: http://hdl.handle.net/2445/226433
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Leadership analysis of institutional authors

the author responsible for correspondence tasks has been Casas Rodríguez, Rosa.

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Awards linked to the item

This research was funded by the company DR Healthcare Espana, S.L.U. (Barcelona, Spain).
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