Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
NCT04798677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2022-07-21
Summary
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions. Innate immunity can adapt and respond more efficiently to secondary exposures, thanks to epigenetic and metabolic reprogramming, namely "trained immunity".
ABBC1 is a combination of beta-1,3/1,6-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity. ABBC1 includes repurposed synergistic yeast-based ingredients: a unique ß-1,3/1,6-glucan complex and a consortium of probiotic Saccharomyces cerevisiae, rich in Selenium and Zinc. ABBC1 induces trained immunity due to its specific chemical and tridimensional structure: its ß-glucan complex interacts with specific receptors in immune cells, provoking a release of cytokines and priming phagocytosis. Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm.
ABBC1 provides highly bioavailable selenium and zinc, micronutrients with a critical role in an optimal immune responsiveness to allergy, infection, and vaccines. ABBC1 possesses proven microbiome modulating properties, which revert in immune training. Due to its high tolerance, safety and immediate availability, ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19, or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines. The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients, including the elderly who are frequently polymedicated, and allows adding an additional therapeutic tool in the fight against the pandemic.
This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021.
Conditions
- Immunity
- Vaccine Reaction
- Influenza
- Covid19
- Cytokine Storm
- Immunologic Deficiency Syndromes
Interventions
- DIETARY_SUPPLEMENT
-
ABBC1 Immunoessential
Powder for dissolution in water, based on a yeast beta-glucan complex and a consortium of Saccharomyces cerevisiae rich in selenium and zinc + excipents. Lemon flavor
- DIETARY_SUPPLEMENT
-
Placebo
Powder for dissolution in water, excipents. Lemon flavor
Sponsors & Collaborators
-
AB Biotek
lead INDUSTRY
Principal Investigators
-
Julián A. Mateus Rodríguez, MD, PhD · Hospital Mare de Deu de la Mercè - Germanes Hositalàries
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-29
- Primary Completion
- 2021-06-10
- Completion
- 2021-09-24
Countries
- Spain
Study Locations
More Related Trials
-
Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function
NCT03518281 ·Status: COMPLETED ·Phase: NA
-
Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19
NCT04323228 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
NCT04468139 ·Status: UNKNOWN ·Phase: PHASE4
-
Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19
NCT04877509 ·Status: COMPLETED
-
The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults
NCT02876315 ·Status: COMPLETED ·Phase: NA
-
Urolithin A Supplementation to Boost Immune Health
NCT05735886 ·Status: COMPLETED ·Phase: NA
-
Ability of Beta-glucan Supplementation to Augment Immune Function
NCT03769012 ·Status: COMPLETED ·Phase: NA
-
The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.
NCT05185934 ·Status: UNKNOWN ·Phase: NA
-
Investigation of the Efficacy of CARDIO Softgels PLUS Best-standard-of-care in the Recovery of Patients With COVID-19
NCT04465513 ·Status: COMPLETED ·Phase: NA
-
Dietary Supplements for COVID-19
NCT04780061 ·Status: TERMINATED ·Phase: PHASE3
-
Immune Diversity Response to Oral Dosing of Nutritional Health Products in Healthy Participants
NCT05242718 ·Status: COMPLETED ·Phase: NA
-
Immunological Effect of Increasing Doses of Natural Peptide
NCT05176678 ·Status: UNKNOWN ·Phase: NA
-
Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
NCT04828668 ·Status: COMPLETED ·Phase: NA
-
Pharmacologic Ascorbic Acid as an Activator of Lymphocyte Signaling for COVID-19 Treatment
NCT04363216 ·Status: UNKNOWN ·Phase: PHASE2
-
Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
NCT05366205 ·Status: UNKNOWN ·Phase: NA
-
Effect of Anatabine on Elevated Blood Levels of C-reactive Protein
NCT01607619 ·Status: COMPLETED ·Phase: NA
-
Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19
NCT04961476 ·Status: COMPLETED
-
Clinical Proof-of-concept Study on Rapid Immune Modulating Effects
NCT05364710 ·Status: UNKNOWN ·Phase: NA
-
Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
NCT01885728 ·Status: COMPLETED ·Phase: NA
-
Acute Effects on Stem Cell Surveillance
NCT07341178 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
NCT04869579 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support
NCT04144673 ·Status: COMPLETED ·Phase: NA
-
Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19
NCT05629975 ·Status: UNKNOWN ·Phase: NA
-
Study of Cannabidiol (CBD) in Healthy Volunteers
NCT06286839 ·Status: COMPLETED ·Phase: NA
-
The Antioxidant Efficacy of a Product Probiotic in Research
NCT03798821 ·Status: COMPLETED ·Phase: NA