Effectiveness of a Dietary Supplement Based on a Synergistic Combination of Beta-Glucans and Saccharomyces Cerevisiae Yeast Enriched With Zinc and Selenium in Allergic Patients Undergoing Subcutaneous Immunotherapy Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effectiveness of the dietary supplement
研究概览
简要总结
The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol. It will also attempt to determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
详细描述
The study's hypothesis is to verify whether the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium is an immunomodulator of innate immunity with antioxidant properties that can strengthen and enhance the immune system response in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
Its ingredients (beta-glucans, Saccharomyces cerevisiae yeast, selenium, and zinc) may provide patients with a balanced immune response during periods of seasonal stress as a result of increased levels of aeroallergens.
Histamine is a biogenic amine involved in numerous physiological systems, including allergic processes. Diamine oxidase (DAO) is an enzyme that metabolizes histamine. Pork kidney extract contains high amounts of DAO enzyme and is marketed for the management of various symptoms related to high levels of histamine in the blood. DAO deficiency has been associated with clinical manifestations of asthma and allergic rhinitis. The aim is to investigate whether DAO supplementation enhances the effect of a dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
This part of the study will be conducted in a separate and subsequent phase (follow-up) to the intake of the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium alone.
The high tolerance, safety, and immediate bioavailability of this dietary supplement could provide beneficial effects on the immune system in an allergic population diagnosed with rhinitis or rhinoconjunctivitis, undergoing subcutaneous ITE treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Multicenter, prospective, controlled group, longitudinal, and randomized study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Both sexes.
- •Patients diagnosed with allergic rhinitis or allergic rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing treatment with subcutaneous polymerized 100 immunotherapy, initiating treatment with rapid dosing.
- •Normoglycemia (fasting glucose ≤ 100 mg/dL).
- •BMI between 18.5-29.9 kg/m².
排除标准
- •Refusal to sign the informed consent.
- •Outside the age range specified for the study.
- •Presence of intolerance or hypersensitivity to selenium or zinc, or to any of the components of the dietary supplement individually.
- •Participation in a clinical trial within the past two months, or currently participating in another study.
- •Personal history of liver or kidney disease.
- •Excessive alcohol consumption (> 20 grams/day) or use of substance abuse.
- •Any condition that, in the opinion of the investigators, renders the subject unable to participate in the study.
研究组 & 干预措施
Placebo Stage 1 (first 90 days)
Control group (n= 30):
Stage 1: Under treatment with subcutaneous immunotherapy (ITE) but not receiving any dietary supplement, serving as a comparison for the variables collected in the study, for 90 days.
干预措施: Specific immunotherapy (SIT) treatment (Drug)
Dietary supplement Stage 1 (first 90 days)
Experimental group (n= 30):
Stage 1: Participants receive the dietary supplement (1 sachet/day; contains 3 grams), in addition to the ITE treatment, for 90 days.
干预措施: Specific immunotherapy (SIT) treatment (Drug)
Placebo Stage 2 (last 90 days)
Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams), but they do not receive the pork extract with diamine oxidase enzyme and serve as a comparison for the variables collected in the study, for 90 days.
干预措施: Specific immunotherapy (SIT) treatment (Drug)
Dietary supplement Stage 2 (last 90 days)
Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams) and mini-tablets with pork extract containing diamine oxidase enzyme (3 mini-tablets/day), for 90 days.
干预措施: Specific immunotherapy (SIT) treatment (Drug)
Dietary supplement Stage 2 (last 90 days)
Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams) and mini-tablets with pork extract containing diamine oxidase enzyme (3 mini-tablets/day), for 90 days.
干预措施: Mini-tablets with pork extract (Dietary Supplement)
结局指标
主要结局
Effectiveness of the dietary supplement
时间窗: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and IgE subclasses (Total IgE, specific IgE, and IgG4) in serum.
次要结局
- Safety (assessment in the different study periods following intake of the dietary supplement)((T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.)
- Monitoring of health status (quality of life) in the different phases of the study using the SF-36 Quality of Life Questionnaire.((T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.)
- TSQM Spanish version questionnaire((T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.)
- • Monitoring treatment compliance/adherence.((T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.)
- SF-36 Quality of Life Questionnaire((T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.)