Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448585
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-04
Brief Title:
Dietary Supplement Beta-Glucans in Allergic Patients Undergoing Subcutaneous Immunotherapy
Sponsor:
Gala Servicios Clinicos SL
Organization:
Gala Servicios Clinicos SL
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study39s 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
General Objective
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
To determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy
Primary Objective
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and subclasses Total IgE specific IgE and IgG4 in serum
Secondary Objectives
Monitoring health status quality of life in the various phases of the study through the application of the SF-36 Quality of Life Questionnaire
This questionnaire measures eight dimensions of health physical functioning role limitations due to physical problems bodily pain social functioning mental health role limitations due to emotional problems vitality-energy-fatigue and general health perception in carrying out daily activities Due to its validity internal consistency and reliability of the recorded data the SF-36 questionnaire is a very useful tool in assessing the physical and mental health status of subjects and their progress in relation to the treatment
Safety evaluation during the various periods of the study after ingestion of the dietary supplement
Recording of adverse events If applicable determining the causal relationship between the adverse event and the ingestion of the dietary supplement
Assessment of the degree of satisfaction with the dietary supplement by the patient TSQM questionnaire Spanish version and by both the doctor and the patient simple Likert satisfaction scale
Control of complianceadherence to the treatment
Evaluate the effectiveness of the combination of the dietary supplement and DAO extract on the immune response in allergic patients through the application of the SF-36 Quality of Life Questionnaire
Study Design
Multicenter prospective controlled longitudinal and randomized study conducted in the allergy clinics of the Extremadura Health Service SES
Study Population
Sixty patients n 60 of both sexes aged between 18 and 65 years diagnosed with rhinitis or rhinoconjunctivitis with or without controlled asthma undergoing subcutaneous polymerized 100 immunotherapy in the initiation phase with a rapid cluster protocol in which the highest concentration of allergen 02 03 mL is injected directly with an interval of 30 to 45 minutes between injections in the allergy clinics of the SES
All patients are required to have the ability to take the dietary supplement orally and to understand the process development for inclusion in the clinical study
Eligibility Criteria
Inclusion Criteria
Age between 18 and 65 years Both sexes Patients diagnosed with allergic rhinitis or rhinoconjunctivitis with or without allergic asthma due to sensitization to aeroallergens undergoing subcutaneous polymerized 100 immunotherapy initiating treatment with a rapid protocol
Normoglycemia fasting glucose 100 mgdl BMI between 185-299 kgm²
Exclusion Criteria
Not signing the informed consent Not within the study age range Intolerance or hypersensitivity to selenium or zinc or to any components of the dietary supplement in isolation
Participation in a clinical trial in the past two months or currently participating in another study
Personal history of liver or kidney diseases Excessive alcohol consumption gt 20 gday or substance abuse Any condition that in the opinion of the investigators disqualifies the subject from participating in the study
Types of Intervention and Procedure
All patients participating in the study are undergoing treatment with subcutaneous polymerized 100 immunotherapy in cluster format
Patients will be randomly assigned to one of the two branches or groups in the study
Experimental Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams in addition to ITE treatment for 90 days
Control Group n 30 Patients are undergoing ITE treatment but do not receive any dietary supplement serving as a comparison for the study variables
At the end of the first blinded phase of the study 90 days all patients will have the opportunity to take ABB C1 openly without a washout phase but they will be randomized into two other groups
Experimental Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams and mini-tablets with pig extract containing diamine oxidase enzyme 3 mini-tabletsday in addition to ITE treatment for 90 days
Control Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams but do not receive pig extract with diamine oxidase enzyme and serve as a comparison for the study variables
Based on the available information provided by the manufacturer the dietary supplement has the following composition per 3-gram sachet mannitol bulking agent beta 1316 glucan polysaccharides from yeast Saccharomyces cerevisiae yeast Saccharomyces cerevisiae enriched with minerals selenium and zinc anhydrous citric acid acidulant lemon flavor silicon dioxide anticaking agent sucralose sweetener
This dietary supplement is gluten-free lactose-free and suitable for vegans
According to the available information provided by the manufacturer the mini-tablets of DAO extract have the following composition microcrystalline cellulose and hydroxypropyl cellulose bulking agents 7 kidney pork protein extract with diamine oxidase DAO ethylcellulose coating agent potato starch medium-chain triglycerides oleic acid and stearic acid stabilizers
The study procedure is identical for all participants n 60 and consists of
Baseline assessment T0 and sample collection before the study Intermediate assessment T1 at 30 days Intermediate assessment T2 at 60 days Final assessment T3 and sample collection at 90 days Follow-up continuation of optional supplementation with ABB C1 for all volunteers who agree to take the product for an additional 90 days including those who were previously randomized to the placebo group follow-up study These volunteers will be re-randomized and assigned to either the ABB C1 DAO group or the ABB C1 group
Final follow-up assessment T4 and sample collection at 180 days
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
General Objective
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
To determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy
Primary Objective
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and subclasses Total IgE specific IgE and IgG4 in serum
Secondary Objectives
Monitoring health status quality of life in the various phases of the study through the application of the SF-36 Quality of Life Questionnaire
This questionnaire measures eight dimensions of health physical functioning role limitations due to physical problems bodily pain social functioning mental health role limitations due to emotional problems vitality-energy-fatigue and general health perception in carrying out daily activities Due to its validity internal consistency and reliability of the recorded data the SF-36 questionnaire is a very useful tool in assessing the physical and mental health status of subjects and their progress in relation to the treatment
Safety evaluation during the various periods of the study after ingestion of the dietary supplement
Recording of adverse events If applicable determining the causal relationship between the adverse event and the ingestion of the dietary supplement
Assessment of the degree of satisfaction with the dietary supplement by the patient TSQM questionnaire Spanish version and by both the doctor and the patient simple Likert satisfaction scale
Control of complianceadherence to the treatment
Evaluate the effectiveness of the combination of the dietary supplement and DAO extract on the immune response in allergic patients through the application of the SF-36 Quality of Life Questionnaire
Study Design
Multicenter prospective controlled longitudinal and randomized study conducted in the allergy clinics of the Extremadura Health Service SES
Study Population
Sixty patients n 60 of both sexes aged between 18 and 65 years diagnosed with rhinitis or rhinoconjunctivitis with or without controlled asthma undergoing subcutaneous polymerized 100 immunotherapy in the initiation phase with a rapid cluster protocol in which the highest concentration of allergen 02 03 mL is injected directly with an interval of 30 to 45 minutes between injections in the allergy clinics of the SES
All patients are required to have the ability to take the dietary supplement orally and to understand the process development for inclusion in the clinical study
Eligibility Criteria
Inclusion Criteria
Age between 18 and 65 years Both sexes Patients diagnosed with allergic rhinitis or rhinoconjunctivitis with or without allergic asthma due to sensitization to aeroallergens undergoing subcutaneous polymerized 100 immunotherapy initiating treatment with a rapid protocol
Normoglycemia fasting glucose 100 mgdl BMI between 185-299 kgm²
Exclusion Criteria
Not signing the informed consent Not within the study age range Intolerance or hypersensitivity to selenium or zinc or to any components of the dietary supplement in isolation
Participation in a clinical trial in the past two months or currently participating in another study
Personal history of liver or kidney diseases Excessive alcohol consumption gt 20 gday or substance abuse Any condition that in the opinion of the investigators disqualifies the subject from participating in the study
Types of Intervention and Procedure
All patients participating in the study are undergoing treatment with subcutaneous polymerized 100 immunotherapy in cluster format
Patients will be randomly assigned to one of the two branches or groups in the study
Experimental Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams in addition to ITE treatment for 90 days
Control Group n 30 Patients are undergoing ITE treatment but do not receive any dietary supplement serving as a comparison for the study variables
At the end of the first blinded phase of the study 90 days all patients will have the opportunity to take ABB C1 openly without a washout phase but they will be randomized into two other groups
Experimental Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams and mini-tablets with pig extract containing diamine oxidase enzyme 3 mini-tabletsday in addition to ITE treatment for 90 days
Control Group n 30 Participants receive the dietary supplement 1 sachetday containing 3 grams but do not receive pig extract with diamine oxidase enzyme and serve as a comparison for the study variables
Based on the available information provided by the manufacturer the dietary supplement has the following composition per 3-gram sachet mannitol bulking agent beta 1316 glucan polysaccharides from yeast Saccharomyces cerevisiae yeast Saccharomyces cerevisiae enriched with minerals selenium and zinc anhydrous citric acid acidulant lemon flavor silicon dioxide anticaking agent sucralose sweetener
This dietary supplement is gluten-free lactose-free and suitable for vegans
According to the available information provided by the manufacturer the mini-tablets of DAO extract have the following composition microcrystalline cellulose and hydroxypropyl cellulose bulking agents 7 kidney pork protein extract with diamine oxidase DAO ethylcellulose coating agent potato starch medium-chain triglycerides oleic acid and stearic acid stabilizers
The study procedure is identical for all participants n 60 and consists of
Baseline assessment T0 and sample collection before the study Intermediate assessment T1 at 30 days Intermediate assessment T2 at 60 days Final assessment T3 and sample collection at 90 days Follow-up continuation of optional supplementation with ABB C1 for all volunteers who agree to take the product for an additional 90 days including those who were previously randomized to the placebo group follow-up study These volunteers will be re-randomized and assigned to either the ABB C1 DAO group or the ABB C1 group
Final follow-up assessment T4 and sample collection at 180 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None