Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646980
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2020-11-15
Brief Title:
BiobranMGN-3 Increases Innate Resistance and Reduces the Incidence of Influenza-like Illnesses
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Dietary Supplementation With BiobranMGN-3 Increases Innate Resistance Against Viral Infections That Cause Influenza-like Illnesses in Elderly Subjects a Randomized Double-blind Placebo-controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Influenza is a seasonally-epidemic viral infection causing 3-5 million severe illnesses and up to approximately 500000 annual deaths around the world Influenza-like illnesses ILI is a simple constellation of symptoms and signs that was introduced to capture influenza cases in surveillance system The elderly are more susceptible to cancers and viral infections including influenza infection and complications that was attributed to the phenomenon of immunosenescence or age-associated decline of immune system activity BiobranMGN3 is a natural nutritional supplement that was shown to exhibit potent immunomodulator effect such as enhancement of natural killer cell NKC activity and up-regulating the production of cytokines such as tumor necrosis factor-α TNF- α interferon-gamma IFN-γ and -lambda IFN-λ The protective effect of BiobranMGN-3 against viral infection such hepatitis C virus HCV and human immunodeficiency virus HIV as well as several cancer types has been previously reported in experimental animal models and humans The objective of the current study was to investigate the effect of BiobranMGN-3 on some innate immune system components and the incidence of ILI in the older adult population The studied innate immune system included NKC activity and the expressions of intracellular viral nucleic acid sensors such as retinoic acid-inducible gene 1 RIG-1 melanoma differentiation-associated protein 5 MDA5 and some of their downstream signals such as ISG15 and MX1
Detailed Description:
The current study investigated the effect of oral supplementation with BiobranMGN-3 500 mg every day for 3 months on several components of innate immune system and the incidence rate of influenza-like illnesses ILI in older adults population The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approval by Institutional Review Board IRB at the Faculty of Medicine Zagazig University Egypt Zagazig University Hospitals serves over 1 million residents in Zagazig district and neighboring towns
The study spanned the time period from November 2018 till the end of February 2019 a period with known peak incidence of ILI attacks Subjects of 56 years were recruited from the visitors of outpatient clinics at Zagazig University Hospitals The age of 56 years was used by the WHO to define old age in African nations In addition this age is close to public service retirement in Egyptian society which is associated with significant social mental and psychological stress and therefore could be associated with significant decline in NK cell activity Only local residents of Zagazig district were recruited to the study so as to reduce the dropout rate
Originally 90 subjects both males and females were approached but only 80 subjects 40 males and 40 females continued the study Ten of the recruits refused to participate when they realized that the sachets were only labeled with the manufacture symbols without printed names which was used to ensure double-blinding Informed consents were obtained from all participants and their right to unconditionally withdraw from the study at any time were made clear to them
Males and females were randomly assigned into two groups n40group that received either placebo or BiobranMGN-3 500 mgday for 3 months Both the health care giver and the participants were blinded to the ingested supplement Participants health was monitored via weekly home visits and they were instructed to report any complaints or side effects by phone to the health care giver
Diagnosis of ILI was made by documenting the incidence of acute respiratory illness with a measured temperature of 38 C with cough 3 After diagnosis the subject was helped to follow the proper health management plan by the health care giver During the study all participants were required not to take any vitamins or medications during the study without consultation
The effect of BiobranMGN-3 on liver kidney and hematological parameters were monitored Liver functions were monitored using alanine aminotransferase ALTSGPT and aspartate aminotransferase ASTSGOT whereas kidney function was monitored using serum uric acid The assessed hematological parameters included red blood cell count RBC hematocrit value HCT hemoglobin Hb mean corpuscular hemoglobin MCH mean corpuscular volume MCV and total and differential WBC
NKC activity was measured using the well documented degranulation assay The viral nucleic acid receptors RIG-1 and MDA5 and their downstream target ISG15 and MX1 were assessed using flowcytometry in BEAS-2B cells
The study spanned the time period from November 2018 till the end of February 2019 a period with known peak incidence of ILI attacks Subjects of 56 years were recruited from the visitors of outpatient clinics at Zagazig University Hospitals The age of 56 years was used by the WHO to define old age in African nations In addition this age is close to public service retirement in Egyptian society which is associated with significant social mental and psychological stress and therefore could be associated with significant decline in NK cell activity Only local residents of Zagazig district were recruited to the study so as to reduce the dropout rate
Originally 90 subjects both males and females were approached but only 80 subjects 40 males and 40 females continued the study Ten of the recruits refused to participate when they realized that the sachets were only labeled with the manufacture symbols without printed names which was used to ensure double-blinding Informed consents were obtained from all participants and their right to unconditionally withdraw from the study at any time were made clear to them
Males and females were randomly assigned into two groups n40group that received either placebo or BiobranMGN-3 500 mgday for 3 months Both the health care giver and the participants were blinded to the ingested supplement Participants health was monitored via weekly home visits and they were instructed to report any complaints or side effects by phone to the health care giver
Diagnosis of ILI was made by documenting the incidence of acute respiratory illness with a measured temperature of 38 C with cough 3 After diagnosis the subject was helped to follow the proper health management plan by the health care giver During the study all participants were required not to take any vitamins or medications during the study without consultation
The effect of BiobranMGN-3 on liver kidney and hematological parameters were monitored Liver functions were monitored using alanine aminotransferase ALTSGPT and aspartate aminotransferase ASTSGOT whereas kidney function was monitored using serum uric acid The assessed hematological parameters included red blood cell count RBC hematocrit value HCT hemoglobin Hb mean corpuscular hemoglobin MCH mean corpuscular volume MCV and total and differential WBC
NKC activity was measured using the well documented degranulation assay The viral nucleic acid receptors RIG-1 and MDA5 and their downstream target ISG15 and MX1 were assessed using flowcytometry in BEAS-2B cells
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