Influenza-like IllnessNCT04646980
Biobran/MGN-3 Increases Innate Resistance and Reduces the Incidence of Influenza-like Illnesses
A study testing Biobran/MGN-3 in people with Influenza-like Illness, run by Zagazig University at 1 site in Egypt.
Trial summary
Influenza is a seasonally-epidemic viral infection causing 3-5 million severe illnesses and up to approximately 500,000 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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Influenza-like Illness
- What is being tested?
- Biobran/MGN-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 56+ years
- Both sexes will be included.
- Local residents of Zagazig district
- Willing to participate in the study and give a written consent.
Who cannot join
- Subjects who took influenza vaccine, cortisone, or any other immunosuppressive agents such as radiation or chemotherapy.
- Diagnosed with infections or malignancies
- Presence of auto-immune disorders
- Marked portal hypertension, pancytopenia, renal, or kidney failure
- Presence of major psychological insult or under medication for psychological insult
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Community Medicine and Public Health, Faculty of Medicine, Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Dietary Supplementation With Biobran/MGN-3 Increases Innate Resistance Against Viral Infections That Cause Influenza-like Illnesses in Elderly Subjects: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Influenza is a seasonally-epidemic viral infection causing 3-5 million severe illnesses and up to approximately 500,000 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. Biobran/MGN3 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 Biobran/MGN-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 Biobran/MGN-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.
Read the detailed description
The current study investigated the effect of oral supplementation with Biobran/MGN-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 (n=40/group) that received either placebo or Biobran/MGN-3 (500 mg/day 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 Biobran/MGN-3 on liver, kidney, and hematological parameters were monitored. Liver functions were monitored using alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT), 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.
- Conditions
- Influenza-like Illness
- Being tested
- Biobran/MGN-3, Placebo
- Keywords
- Biobran/MGN-3, Old adults, influenza-like illness, NK cells activity, Degranulation assay, RIG-1, MDA5, ISG15, MX1
- Medical subject headings
- gaze palsy, familial horizontal, with progressive scoliosis, Diabetes Mellitus, Insulin-Dependent, 19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobran/MGN-3Dietary supplement
Biobran/MGN3 is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as a food supplement. Biobran/MGN3 is manufactured by hydrolyzing rice bran with the enzymatic extract of medicinal Shiitake mushrooms. Enzyme hydrolysis of rice bran produces arabinoxylane, a hemi-cellulose compound, which constitutes the active ingredient of biobran/MGN3.
PlaceboOther
Placebo, with same appearance and taste as Biobran/MGN-3, was given to control subjects at a dose of 500 mg everyday for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Biobran/MGN-3 | Experimental | This arm consisted from 20 males and 20 females. Biobran/MGN-3 was orally supplemented at dose of 500 mg per day for 3 months (end of November 2018- end of February 2019). Receives: Dietary Supplement: Biobran/MGN-3 |
| Placebo | Placebo comparator | This arm consisted from 20 males and 20 females. Placebo, with the same appearance and taste, was orally supplemented at dose of 500 mg per day for 3 months (end of November 2018- end of February 2019). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ILI incidence rate
Incidence rate was calculated by dividing the number of incident ILI cases by the total number of the group participants during the 3 months study period.
Measured: 12 weeks
ILI incidence density
incidence density was calculated by dividing the number of incident cases by the total person-time at risk
Measured: 3600 Person-days
NK cell activity
Percentage of NK cells (CD56-positive CD3-negative) expressing CD-107a
Measured: 12 weeks
RIG-1, MDA5, ISG15, MX1 expression
Expression levels in BEAS-2B cells tissue culture exposed to Biobran/MGN-3
Measured: 72 hours
Secondary outcomes (1)
Natural killer T-cells (NKT) cell activity
Percentage of NK cells (CD56-positive CD3-positive) expressing CD-107a
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start28 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza-like IllnessStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Charles Drew University of Medicine and Science, University of California, Irvine, Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan
- Responsible party
- Principal investigator, Ahmed Farouk Elsaid, Zagazig University
- Investigators
- Ahmed F Elsaid, MD/PhD, Principal investigator, Department of Community Medicine and Public Health, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646980
- Sponsor's protocol ID
- 4034-12-6-2018
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share results upon request.
Publications
Elsaid AF, Shaheen M, Ghoneum M. Biobran/MGN-3, an arabinoxylan rice bran, enhances NK cell activity in geriatric subjects: A randomized, double-blind, placebo-controlled clinical trial. Exp Ther Med. 2018 Mar;15(3):2313-2320. doi: 10.3892/etm.2018.5713. Epub 2018 Jan 8.
PubMed 29456638Elsaid AF, Fahmi RM, Shaheen M, Ghoneum M. The enhancing effects of Biobran/MGN-3, an arabinoxylan rice bran, on healthy old adults' health-related quality of life: a randomized, double-blind, placebo-controlled clinical trial. Qual Life Res. 2020 Feb;29(2):357-367. doi: 10.1007/s11136-019-02286-7. Epub 2019 Sep 5.
PubMed 31489525
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation With Biobran/MGN-3 Increases Innate Resistance Against Viral Infections That Cause Influenza-like Illnesses in Elderly Subjects: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04646980
- Acronym / sponsor ID
- 4034-12-6-2018
- Conditions
- Influenza-like Illness
- Keywords
- Biobran/MGN-3, Old adults, influenza-like illness, NK cells activity, Degranulation assay, RIG-1, MDA5, ISG15, MX1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Charles Drew University of Medicine and Science, University of California, Irvine, Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza is a seasonally-epidemic viral infection causing 3-5 million severe illnesses and up to approximately 500,000 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. Biobran/MGN3 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 Biobran/MGN-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 Biobran/MGN-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 Biobran/MGN-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 (n=40/group) that received either placebo or Biobran/MGN-3 (500 mg/day 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 Biobran/MGN-3 on liver, kidney, and hematological parameters were monitored. Liver functions were monitored using alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT), 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Biobran/MGN-3 | Experimental | Dietary Supplement: Biobran/MGN-3This arm consisted from 20 males and 20 females. Biobran/MGN-3 was orally supplemented at dose of 500 mg per day for 3 months (end of November 2018- end of February 2019). |
| Placebo | Placebo comparator | Other: PlaceboThis arm consisted from 20 males and 20 females. Placebo, with the same appearance and taste, was orally supplemented at dose of 500 mg per day for 3 months (end of November 2018- end of February 2019). |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages of 56+ years
- Both sexes will be included.
- Local residents of Zagazig district
- Willing to participate in the study and give a written consent.
Key exclusion criteria (5 listed)
- Subjects who took influenza vaccine, cortisone, or any other immunosuppressive agents such as radiation or chemotherapy.
- Diagnosed with infections or malignancies
- Presence of auto-immune disorders
- Marked portal hypertension, pancytopenia, renal, or kidney failure
- Presence of major psychological insult or under medication for psychological insult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobran/MGN-3Biobran/MGN3 is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as a food supplement. Biobran/MGN3 is manufactured by hydrolyzing rice bran with the enzymatic extract of medicinal Shiitake mushrooms. Enzyme hydrolysis of rice bran produces arabinoxylane, a hemi-cellulose compound, which constitutes the active ingredient of biobran/MGN3. | Dietary supplement | Biobran/MGN-3 |
| PlaceboPlacebo, with same appearance and taste as Biobran/MGN-3, was given to control subjects at a dose of 500 mg everyday for 3 months | Other | Placebo |
Primary outcome
ILI incidence rate
Time frame: 12 weeks
Incidence rate was calculated by dividing the number of incident ILI cases by the total number of the group participants during the 3 months study period.
ILI incidence density
Time frame: 3600 Person-days
incidence density was calculated by dividing the number of incident cases by the total person-time at risk
NK cell activity
Time frame: 12 weeks
Percentage of NK cells (CD56-positive CD3-negative) expressing CD-107a
RIG-1, MDA5, ISG15, MX1 expression
Time frame: 72 hours
Expression levels in BEAS-2B cells tissue culture exposed to Biobran/MGN-3
1 secondary outcome
Natural killer T-cells (NKT) cell activity
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Results publication: PubMed 29456638Elsaid AF, Shaheen M, Ghoneum M. Biobran/MGN-3, an arabinoxylan rice bran, enhances NK cell activity in geriatric subjects: A randomized, double-blind, placebo-controlled clinical trial. Exp Ther Med. 2018 Mar;15(3):2313-2320. doi: 10.3892/etm.2018.5713. Epub 2018 Jan 8.
- Results publication: PubMed 31489525Elsaid AF, Fahmi RM, Shaheen M, Ghoneum M. The enhancing effects of Biobran/MGN-3, an arabinoxylan rice bran, on healthy old adults' health-related quality of life: a randomized, double-blind, placebo-controlled clinical trial. Qual Life Res. 2020 Feb;29(2):357-367. doi: 10.1007/s11136-019-02286-7. Epub 2019 Sep 5.
- Individual participant dataSharing planned: Yes. Share results upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed F Elsaid, MD/PhD principal investigator
Department of Community Medicine and Public Health, Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobran/MGN-3 in people with Influenza-like Illness, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ILI incidence rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.