Advertisement

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

  • A. F. Elsaid
  • R. M. Fahmi
  • M. Shaheen
  • M. GhoneumEmail author
Article

Abstract

Purpose

The world’s older population is growing rapidly and the need to find measures to combat age-associated decline of physical, mental, and cognitive functions and improve their health-related quality of life (HRQOL) is escalating. Biobran/MGN-3, an arabinoxylan rice bran, has been previously reported to improve the quality of life in cancer patients. The objective of the current study was to examine the effect of a low dose of Biobran/MGN-3 supplementation on the HRQOL in a healthy older adult population.

Methods

Sixty apparently healthy subjects, 40 males and 20 females, over 56 years old were recruited and blindly randomized into two group receiving either placebo or Biobran/MGN-3 (250 mg/day for 3 months). Participants did not take any vitamins or medications during the study and their health was closely monitored. HRQOL was assessed at the initiation and termination of the study using the previously validated Arabic version of SF-12v2 questionnaire.

Results

For all measured HRQOL domains, there was no statistically significant difference in baseline scores between the two groups. Compared to baseline values and placebo-treated subjects, Biobran/MGN-3 supplementation significantly enhanced the levels of physical and mental component summary scores as well as role-physical, bodily pain, vitality, and social functioning subdomain scores.

Conclusion

These results show that Biobran/MGN-3 is a promising psychoneuroimmune modulatory agent that could improve the HRQOL in healthy old adults.

Keywords

Biobran/MGN-3 Older adults Health-related quality of life Social behavior Cognitive activity 

Abbreviations

HRQOL

Health-related Quality of Life

PCS

Physical Component Summary

MCS

Mental Component Summary

PF

Physical Functioning

RP

Role-Physical

RE

Role Emotion

BP

Bodily Pain

MH

Mental Health

VT

Vitality

SF

Social Functioning

WHO

World Health Organization

QOL

Quality of Life

GH

General Health

PA

Physical Activity

Notes

Acknowledgements

The authors would like to thank Daiwa Pharmaceutical Co., Ltd., Tokyo, Japan for providing Biobran/MGN-3. We also appreciate the assistance of Dr. B. J. Winjum in preparing the manuscript.

Compliance with ethical standards

Conflict of interest

Dr. Elsaid, Dr. Fahmi, and Dr. Shaheen have nothing to disclose; Dr. Ghoneum has received grants from Daiwa Pharmaceutical Co., Ltd., Japan, outside the submitted work.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Zagazig University Hospital, Faculty of Medicine, IRB approval no. 1507, June 2018) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

11136_2019_2286_MOESM1_ESM.docx (14 kb)
Supplementary material 1 (DOCX 13 kb)

References

  1. 1.
    He, W., Goodkind, D., & Kowal, P. (2016). An aging world: 2015. Washington, DC: U.S. Census Bureau, International Population Reports, U.S. Government Publishing Office.Google Scholar
  2. 2.
    United Nations, Department of Economic and Social Affairs, Population Division. (2017). World population aging 2017- highlights. (ST/ESA/SER.A/397).Google Scholar
  3. 3.
    World Health Organization. (2002). “Proposed working definition of an older person in Africa for the MDS Project.” Retrieved July 11, 2019, from http://www.who.int/healthinfo/survey/ageingdefnolder/en/index.html.
  4. 4.
    Kennedy, B. K., Berger, S. L., Brunet, A., Campisi, J., Cuervo, A. M., Epel, E. S., et al. (2014). Geroscience: Linking aging to chronic disease. Cell, 159, 709–713.CrossRefGoogle Scholar
  5. 5.
    WHO. Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19–22 June, 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no 2, p. 100) and entered into force on 7 April 1948.Google Scholar
  6. 6.
    Kuyken, W., & Group, T.W. (1995). The World Health Organization Quality of Life assessment (WHOQOL): Position paper from the World Health Organization. Social Science and Medicine, 41, 1403–1409.CrossRefGoogle Scholar
  7. 7.
    Hays, R. D., & Reeve, B. B. (2010). Measurement and modeling of health-related quality of life. In J. Killewo, H. K. Heggenhougen, & S. R. Quah (Eds.), Epidemiology and demography in public health (pp. 195–205). San Diego: Academic Press.Google Scholar
  8. 8.
    Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. Journal of the American Medical Association, 273, 59–65.CrossRefGoogle Scholar
  9. 9.
    Carr, A. J., & Higginson, I. J. (2001). Are quality of life measures patient centered? British Medical Journal, 322, 1357.CrossRefGoogle Scholar
  10. 10.
    Ware, J. E., Kosinski, M., Turner Bowker, D. M., & Gandek, B. (2002). How to score version 2 of the SF-12 health survey. Lincoln: Quality Metrics.Google Scholar
  11. 11.
    Cheak-Zamora, N. C., Wyrwich, K. W., & McBride, T. D. (2009). Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Quality of Life Research, 18, 727–735.CrossRefGoogle Scholar
  12. 12.
    Islam, N., Khan, I. H., Ferdous, N., & Rasker, J. J. (2017). Translation, cultural adaptation and validation of the English “Short form SF 12v2” into Bengali in rheumatoid arthritis patients. Health and Quality of Life Outcomes, 15, 109.CrossRefGoogle Scholar
  13. 13.
    Montazeri, A., Vahdaninia, M., Mousavi, S. J., Asadi-Lari, M., Omidvari, S., & Tavousi, M. (2011). The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2): A population-based validation study from Tehran, Iran. Health and Quality of Life Outcomes, 9, 12.CrossRefGoogle Scholar
  14. 14.
    Monteagudo Piqueras, O., Hernando Arizaleta, L., & Palomar Rodriguez, J. A. (2009). Reference values of the Spanish version of the SF-12v2 for the diabetic population. Gaceta Sanitaria, 23, 526–532.CrossRefGoogle Scholar
  15. 15.
    Kim, S. H., Jo, M. W., Ahn, J., Ock, M., Shin, S., & Park, J. (2014). Assessment of psychometric properties of the Korean SF-12 v2 in the general population. BMC Public Health, 14, 1086.CrossRefGoogle Scholar
  16. 16.
    Obtel, M., El Rhazi, K., Elhold, S., Benjelloune, M., Gnatiuc, L., & Nejjari, C. (2013). Crosscultural adaptation of the 12-Item Short-Form survey instrument in a Moroccan representative Survey. Southern African Journal of Epidemiology and Infection, 28, 166–171.CrossRefGoogle Scholar
  17. 17.
    Fleishman, J. A., Selim, A. J., & Kazis, L. E. (2010). Deriving SF-12v2 physical and mental health summary scores: A comparison of different scoring algorithms. Quality of Life Research, 19, 231–241.CrossRefGoogle Scholar
  18. 18.
    Taft, C. (2001). Reply to Drs Ware and Kosinski. Quality of Life Research, 10, 415–420.CrossRefGoogle Scholar
  19. 19.
    Zachariae, R. (2009). Psychoneuroimmunology: A bio-psycho-social approach to health and disease. Scandinavian Journal of Psychology, 50(6), 645–651.CrossRefGoogle Scholar
  20. 20.
    Antoni, H. M. (2003). Psychoneuroendocrinology and psychoneuroimmunology of cancer: Plausible mechanisms worth pursuing? Brain, Behavior, and Immunity, 17(Suppl 1), S84–S91.CrossRefGoogle Scholar
  21. 21.
    Green McDonald, P., O’Connell, M., & Lutgendorf, S. K. (2013). Psychoneuroimmunology and cancer: A decade of discovery, paradigm shifts, and methodological innovations. Brain, Behavior, and Immunity, 30(Suppl), S1–S9.CrossRefGoogle Scholar
  22. 22.
    Vitlic, A., Lord, J. M., & Philips, A. C. (2014). Stress, ageing and their influence on functional, cellular and molecular aspects of the immune system. Age., 36, 1169–1185.CrossRefGoogle Scholar
  23. 23.
    Morey, J. N., Boggero, I. A., Scott, A. B., & Segerstrom, S. C. (2015). Current directions in stress and human immune function. Current Opinion in Psychology., 5, 13–17.CrossRefGoogle Scholar
  24. 24.
    Sartori, A. C., Vance, D. E., Slater, L. Z., & Crowe, M. (2012). The impact of inflammation on cognitive function in older adults: Implications for healthcare practice and research. Journal of Neuroscience Nursing, 44, 206–217.CrossRefGoogle Scholar
  25. 25.
    Bhattacharya, A., Derecki, N. C., Lovenberg, T. W., & Drevets, W. C. (2016). Role of neuro-immunological factors in the pathophysiology of mood disorders. Psychopharmacology (Berl), 233, 1623–1636.CrossRefGoogle Scholar
  26. 26.
    Li, C. T., Chen, M. H., Lin, W. C., Hong, C. J., Yang, B. H., Liu, R. S., et al. (2016). The effects of low-dose ketamine on the prefrontal cortex and amygdala in treatment-resistant depression: A randomized controlled study. Human Brain Mapping, 37, 1080–1090.CrossRefGoogle Scholar
  27. 27.
    Noaman, E., Badr El-Din, N. K., Bibars, M. A., Abou Mossallam, A. A., & Ghoneum, M. (2008). Antioxidant potential by arabinoxylan rice bran, MGN-3/biobran, represents a mechanism for its oncostatic effect against murine solid Ehrlich carcinoma. Cancer Letters, 268, 348–359.CrossRefGoogle Scholar
  28. 28.
    Badr El-Din, N. K., Noaman, E., & Ghoneum, M. (2008). In vivo tumor inhibitory effects of nutritional rice bran supplement MGN-3/Biobran on Ehrlich carcinoma-bearing mice. Nutrition and Cancer, 60, 235–244.CrossRefGoogle Scholar
  29. 29.
    Takahara, K., & Sano, K. (2004). The life prolongation and QOL improvement effect of rice bran arabinoxylan derivative (MGN-3. Bio-Bran) for progressive cancer. Clinical Pharmacology and Therapeutics, 14, 267–271.Google Scholar
  30. 30.
    Hajto, T., Horvath, A., & Papp, S. (2016). Improvement of quality of life in tumor patients after an immunomodulatory treatment with standardized mistletoe lectin and arabinoxylan plant extracts. International Journal of Neurorehabilitation, 3, 1–3.CrossRefGoogle Scholar
  31. 31.
    Kawai, T. (2004). A case of a patient with umbilical metstasis of recurrent cancer (Sister Mary Joseph’s Nodule, SMJN) who has survived for a long time under immunomodulatory supplement therapy. Clinical Pharmacology and Therapeutics, 14, 281–288.Google Scholar
  32. 32.
    Ghoneum, M. (1998). Anti-HIV activity in vitro of MGN-3, an activated arabinoxylane from rice bran. Biochemical and Biophysical Research Communications, 243, 25–29.CrossRefGoogle Scholar
  33. 33.
    Ware, J. E., Keller, S. D., Gandek, B., Brazier, J. E., & Sullivan, M. (1995). Evaluating translations of health status questionnaires. Methods from the IQOLA project. International Quality of Life Assessment. International Journal of Technology Assessment in Health Care., 11, 525–551.CrossRefGoogle Scholar
  34. 34.
    Elsaid, A. F., Shaheen, M., & Ghoneum, M. (2018). Biobran/MGN-3, an arabinoxylan rice bran, enhances NK cell activity in geriatric subjects: A randomized, double-blind, placebo-controlled clinical trial. Experimental and Therapeutic Medicine, 15, 2313–2320.Google Scholar
  35. 35.
    Bang, M. H., Van Riep, T., Thinh, N. T., le Song, H., Dung, T. T., Van Truong, L., et al. (2010). Arabinoxylan rice bran (MGN-3) enhances the effects of interventional therapies for the treatment of hepatocellular carcinoma: A three-year randomized clinical trial. Anticancer Research, 30, 5145–5151.Google Scholar
  36. 36.
    Warburton, D. E., Nicol, C. W., & Bredin, S. S. (2006). Health benefits of physical activity: The evidence. Canadian Medical Association Journal, 174, 801–809.CrossRefGoogle Scholar
  37. 37.
    Hong, S. Y., Hughes, S., & Prohaska, T. (2008). Factors affecting exercise attendance and completion in sedentary older adults: A meta-analytic approach. Journal of Physical Activity and Health, 5, 385–397.CrossRefGoogle Scholar
  38. 38.
    Hupin, D., Roche, F., Gremeaux, V., Chatard, J. C., Oriol, M., Gaspoz, J. M., et al. (2015). Even a low-dose of moderate-to-vigorous physical activity reduces mortality by 22% in adults aged ≥ 60 years: A systematic review and meta-analysis. British Journal of Sports Medicine, 49(19), 1262–1267.CrossRefGoogle Scholar
  39. 39.
    Kohl, H. W., Craig, C. L., Lambert, E. V., Inoue, S., Alkandari, J. R., Leetongin, G., et al. (2012). The pandemic of physical inactivity: Global action for public health. Lancet, 380, 294–305.CrossRefGoogle Scholar
  40. 40.
    Carlson, S. A., Fulton, J. E., Schoenborn, C. A., & Loustalot, F. (2010). Trend and prevalence estimates based on the 2008 Physical Activity Guidelines for Americans. American Journal of Preventive Medicine, 39, 305–313.CrossRefGoogle Scholar
  41. 41.
    Kruger, J., Carlson, S. A., & Buchner, D. (2007). How active are older Americans? Preventing Chronic Disease, 4, A53.Google Scholar
  42. 42.
    World Health Organization. (2010). Global recommendations on physical activity for health. Geneva: World Health Organization.Google Scholar
  43. 43.
    Sun, F., Norman, I. J., & While, A. E. (2013). Physical activity in older people: A systematic review. BMC Public Health, 13, 449.CrossRefGoogle Scholar
  44. 44.
    Luthy, C., Cedraschi, C., Allaz, A. F., Herrmann, F. R., & Ludwig, C. (2015). Health status and quality of life: Results from a national survey in a community-dwelling sample of elderly people. Quality of Life Research, 24, 1687–1696.CrossRefGoogle Scholar
  45. 45.
    Cedraschi, C., Luthy, C., Allaz, A. F., Herrmann, F. R., & Ludwig, C. (2016). Low back pain and health-related quality of life in community-dwelling older adults. European Spine Journal, 25, 2822–2832.CrossRefGoogle Scholar
  46. 46.
    Hicks, G. E., Gaines, J. M., Shardell, M., & Simonsick, E. M. (2008). Associations of back and leg pain with health status and functional capacity of older adults: Findings from the retirement community back pain study. Arthritis & Rheumatology, 59, 1306–1313.CrossRefGoogle Scholar
  47. 47.
    Morelli, S. A., Lieberman, M. D., & Zaki, J. (2015). The emerging study of positive empathy. Social and Personality Psychology Compass, 9, 57–68.CrossRefGoogle Scholar
  48. 48.
    Gow, A. J., Corley, J., Starr, J. M., & Deary, I. J. (2013). Which social network or support factors are associated with cognitive abilities in old age? Gerontology, 59, 454–463.CrossRefGoogle Scholar
  49. 49.
    O’Luanaigh, C., O’Connell, H., Chin, A. V., Hamilton, F., Coen, R., Walsh, C., et al. (2012). Loneliness and cognition in older people: the Dublin Healthy Ageing study. Aging & Mental Health, 16, 347–352.CrossRefGoogle Scholar
  50. 50.
    Cole, S. W., Hawkley, L. C., Arevalo, J. M. G., & Cacioppo, J. T. (2011). Transcript origin analysis identifies antigen presenting cells as primary targets of socially regulated leukocyte gene expression. Proceedings of the National academy of Sciences of the United States of America, 15, 3080–3085.CrossRefGoogle Scholar
  51. 51.
    Creswell, J. D., Irwin, M. R., Burklund, L. J., Lieberman, M. D., Arevalo, J. M. G., Ma, J., et al. (2012). Mindfulness-based stress reduction training reduces loneliness and pro-inflammatory gene expression in older adults: A small randomized controlled trial. Brain, Behavior, and Immunity, 26, 1095–1101.CrossRefGoogle Scholar
  52. 52.
    Berra, K. (2003). The effect of lifestyle interventions on quality of life and patient satisfaction with health and health care. Journal of Cardiovascular Nursing, 18, 319–325.CrossRefGoogle Scholar
  53. 53.
    Borg, C., Hallberg, I. R., & Blomqvist, K. (2006). Life satisfaction among older people (65+) with reduced self-care capacity: The relationship to social, health and financial aspects. Journal of Clinical Nursing, 15, 607–618.CrossRefGoogle Scholar
  54. 54.
    Ader, R., Cohen, N., & Felten, D. (1995). Psychoneuroimmunology: Interactions between the nervous system and the immune system. Lancet, 345, 99–103.CrossRefGoogle Scholar
  55. 55.
    Tracey, K. J. (2009). Reflex control of immunity. Nature Reviews Immunology, 9, 418–428.CrossRefGoogle Scholar
  56. 56.
    Pavlov, V. A., & Tracey, K. J. (2015). Neural circuitry and immunity. Immunologic Research, 63, 38–57.CrossRefGoogle Scholar
  57. 57.
    Schiepers, O. J., Wichers, M. C., & Maes, M. (2005). Cytokines and major depression. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 29, 201–217.CrossRefGoogle Scholar
  58. 58.
    Lotrich, F. E. (2015). Inflammatory cytokine-associated depression. Brain Research, 1617, 113–125.CrossRefGoogle Scholar
  59. 59.
    Zhang, X., Du, Q., Liu, C., Yang, Y., Wang, J., Duan, S., et al. (2016). Rhodioloside ameliorates depressive behavior via up-regulation of monoaminergic system activity and anti-inflammatory effect in olfactory bulbectomized rats. International Immunopharmacology, 36, 300–304.CrossRefGoogle Scholar
  60. 60.
    Pacheco, R., Prado, C. E., Barrientos, M. J., & Bernales, S. (2009). Role of dopamine in the physiology of T-cells and dendritic cells. Journal of Neuroimmunology, 216, 8–19.CrossRefGoogle Scholar
  61. 61.
    Rosas-Ballina, M., Olofsson, P. S., Ochani, M., Valdés-Ferrer, S. I., Levine, Y. A., Reardon, C., et al. (2011). Acetylcholine-synthesizing T cells relay neural signals in a vagus nerve circuit. Science, 334, 98–101.CrossRefGoogle Scholar
  62. 62.
    Duggal, N. A., Upton, J., Phillips, A. C., Hampson, P., & Lord, J. M. (2015). NK cell immunesenescence is increased by psychological but not physical stress in older adults associated with raised cortisol and reduced perforin expression. Age (Dordrecht, Netherlands), 37, 9748.CrossRefGoogle Scholar
  63. 63.
    Irwin, M., Patterson, T., Smith, T. L., Caldwell, C., Brown, S. A., Gillin, J. C., et al. (1990). Reduction of immune function in life stress and depression. Biological Psychiatry, 27, 22–30.CrossRefGoogle Scholar
  64. 64.
    Maydych, V., Claus, M., Dychus, N., Ebel, M., Damaschke, J., Diestel, S., et al. (2017). Impact of chronic and acute academic stress on lymphocyte subsets and monocyte function. PLoS ONE, 12, e0188108.CrossRefGoogle Scholar
  65. 65.
    Glaser, R., Rice, J., Speicher, C. E., Stout, J. C., & Kiecolt-Glaser, J. K. (1986). Stress depresses interferon production by leukocytes concomitant with a decrease in natural killer cell activity. Behavioral Neuroscience, 100, 675–678.CrossRefGoogle Scholar
  66. 66.
    Kiecolt-Glaser, J. K., Garner, W., Speicher, C., Penn, G. M., Holliday, J., & Glaser, R. (1984). Psychosocial modifiers of immunocompetence in medical students. Psychosomatic Medicine, 46, 7–14.CrossRefGoogle Scholar
  67. 67.
    Glaser, R., Kiecolt-Glaser, J. K., Stout, J. C., Tarr, K. L., Speicher, C. E., & Holliday, J. E. (1985). Stress-related impairments in cellular immunity. Psychiatry Research, 16, 233–239.CrossRefGoogle Scholar
  68. 68.
    Frick, L. R., Arcos, M. L., Rapanelli, M., Zappia, M. P., Brocco, M., Mongini, C., et al. (2009). Chronic restraint stress impairs T-cell immunity and promotes tumor progression in mice. Stress, 12, 134–143.CrossRefGoogle Scholar
  69. 69.
    Kiecolt-Glaser, J. K., Glaser, R., Shuttleworth, E. C., Dyer, C. S., Ogrocki, P., & Speicher, C. E. (1987). Chronic stress and immunity in family caregivers of Alzheimer’s disease victims. Psychosomatic Medicine, 49, 523–535.CrossRefGoogle Scholar
  70. 70.
    Ghoneum, M. (1998). Enhancement of human natural killer cell activity by modified arabinoxylan from rice bran (MGN-3). International Journal of Immunotherapy, 14, 89–99.Google Scholar
  71. 71.
    Ghoneum, M., & Agrawal, S. (2011). Activation of human monocyte-derived dendritic cells in vitro by the biological response modifier arabinoxylan rice bran (MGN-3/Biobran). International Journal of Immunopathology and Pharmacology, 24, 941–948.CrossRefGoogle Scholar
  72. 72.
    Ghoneum, M., & Agrawal, S. (2014). MGN-3/Biobran enhances generation of cytotoxic CD8 + T cells via upregulation of dec-205 expression on dendritic cells. International Journal of Immunopathology and Pharmacology, 27, 523–530.CrossRefGoogle Scholar
  73. 73.
    Chiossone, L., Dumas, P. Y., Vienne, M., & Vivier, E. (2018). Natural killer cells and other innate lymphoid cells in cancer. Nature Reviews Immunology, 18, 671–688.CrossRefGoogle Scholar
  74. 74.
    Anguille, S., Smits, E. L., Lion, E., van Tendeloo, V. F., & Berneman, Z. N. (2014). Clinical use of dendritic cells for cancer therapy. Lancet Oncology, 15, e257–e267.CrossRefGoogle Scholar
  75. 75.
    Chrisikos, T. T., Zhou, Y., Slone, N., Babcock, R., Watowich, S. S., & Li, H. S. (2018). Molecular regulation of dendritic cell development and function in homeostasis, inflammation, and cancer. Molecular Immunology, 110, 24–39.CrossRefGoogle Scholar
  76. 76.
    Lorusso, L., Mikhaylova, S. V., Capelli, E., Ferrari, D., Ngonga, G. K., & Ricevuti, G. (2009). Immunological aspects of chronic fatigue syndrome. Autoimmunity Reviews, 8, 287–291.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • A. F. Elsaid
    • 1
  • R. M. Fahmi
    • 2
  • M. Shaheen
    • 3
  • M. Ghoneum
    • 4
    Email author
  1. 1.Department of Community Medicine and Public HealthZagazig UniversityZagazigEgypt
  2. 2.Department of Neurology, Faculty of MedicineZagazig UniversityZagazigEgypt
  3. 3.Department of Internal MedicineCharles R. Drew University of Medicine and ScienceLos AngelesUSA
  4. 4.Department of SurgeryCharles R. Drew University of Medicine and ScienceLos AngelesUSA

Personalised recommendations