Biobran/MGN-3 Increases Innate Resistance and Reduces the Incidence of Influenza-like Illnesses

NCT04646980 | Completed DMC

• 1 other identifier: 4034-12-6-2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Influenza-like Illness

Keywords

Biobran/MGN-3; Old adults; influenza-like illness; NK cells activity; Degranulation assay; RIG-1, MDA5, ISG15, MX1

Outcome Measures

Primary Outcomes (4)

• 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.

  12 weeks

• ILI incidence density

  incidence density was calculated by dividing the number of incident cases by the total person-time at risk

  3600 Person-days

• NK cell activity

  Percentage of NK cells (CD56-positive CD3-negative) expressing CD-107a

  12 weeks

• RIG-1, MDA5, ISG15, MX1 expression

  Expression levels in BEAS-2B cells tissue culture exposed to Biobran/MGN-3

  72 hours

Secondary Outcomes (1)

• Natural killer T-cells (NKT) cell activity

  12 weeks

Study Arms (2)

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).

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).

Other: Placebo

Interventions

Biobran/MGN-3 DIETARY_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.

Biobran/MGN-3

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead
• Charles Drew University of Medicine and Science: collaborator
• University of California, Irvine: collaborator
• Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan: collaborator

Study Sites (1)

Department of Community Medicine and Public Health, Faculty of Medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (2)

• 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.

  PMID: 29456638 RESULT

• Elsaid 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.

  PMID: 31489525 RESULT

MeSH Terms

Conditions

gaze palsy, familial horizontal, with progressive scoliosis; Diabetes Mellitus, Insulin-Dependent, 19

Interventions

polysaccharide MGN3

Study Officials

• Ahmed F Elsaid, MD/PhD

  Department of Community Medicine and Public Health, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Care Provider)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Community Medicine and Public Health

Model Details: Randomized double-blind placebo-controlled

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 30, 2020
• Study Start: November 28, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon request

Locations

EG (1)