Bioiberica research supports DAOgest efficacy against histamine intolerance
The study, published in the journal Clinical Nutrition, reported reduced severity of the allergic effects evaluated in a group of 82 participants with HIT who consumed Histamine Digest, a supplement containing Bioiberica's DAOgest-branded enzyme during a four-week intervention.
The European Commission granted DAOgest Novel Food Status last spring, which allows for the ingredient to be marketed in Europe.
Histamine intolerance solutions needed
DAO is naturally present in the gastrointestinal tract, where it breaks down ingested histamine from food. When the body fails to produce sufficient DAO enzymes, effects of HIT arise due to excess histamine in the body, leading to allergy symptoms.
“Histamine intolerance continues to be a prevalent yet largely unaddressed digestive health issue,” Andrea Terradillos, R&D project manager at Bioiberica, told NutraIngredients. “The decision to conduct an observational study was driven by the complex nature of identifying individuals with the condition and the scarcity of robust studies examining the real-world effects of histamine intolerance solutions."
She added that given the discomfort associated with HIT symptoms, it would have been unethical to include a placebo arm in the study.
Wide ranging effects can include gastrointestinal problems, skin issues, headaches and cold-like symptoms, with too high a percentage of the population living without a solution, said Antonio Vendrell, marketing and communications director at Bioiberica.
Impact on all HIT symptoms
Participants were instructed to take a capsule containing 4.2mg of DAOgest, vitamin C and catalase daily before a meal.
The effects of HIT were evaluated using a standardized questionnaire at baseline and every week until the end of the study period. The questionnaire evaluated the severity (0-5) of five HIT-symptom subcategories: nervous system, gastrointestinal, respiratory, skin and circulatory.
Perception of recovery was self-assessed, and the percentage of change from baseline visit in sub-scores was analyzed using a two-sided inferential statistics t-test.
Results showed significant improvements from the baseline visit for all effects of HIT subcategories at week 1: More than 90% in gastrointestinal and skin symptoms, more than 80% in nervous and respiratory and up to 38% in circulatory symptoms.
These improvements were maintained throughout the rest of the studied period, with no differences reported between week one and week four.
"The timeline is particularly significant in this new study, as all patients with allergy-like symptoms showed an improvement of more than 90% in only one week," Terradillos commented, explaining that DAOgest could now offer a real solution to those suffering from HIT.
Perception of recovery was more than 50% for 85% of the participants, except for circulatory symptoms. Additionally, no adverse events associated with the oral supplement were recorded.
"The observational study was interesting because it gives a clear idea on real cases and testimonials," Vendrell said, noting that Bioiberica is considering conducting another observational study towards the end of the year.
The results were consistent with previous Bioiberica research concluding that the combination with vitamin C increases the enzymatic activity of DAO.
“Our advice for formulators in the space is to pair DAOgest with vitamin C as it boosts the histamine degrading capacity of DAO and consequent histamine breakdown,” Terradillos added.
Journal: Clinical Nutrition
“Observational study to assess the efficacy and safety of diamine oxidase (DAO) supplementation in patients with histamine intolerance.”
doi: 10.1016/j.clnesp.2023.09.892
Authors: O’Connor ME et al.
