Moducare Supplement

Moducare Supplement

Moducare® is a proprietary mix of plant sterols and sterolins in a clinically proven ratio of 100:1. This mixture is derived from a natural pine source and is encapsulated in a base of rice flour. The recommended dosage is one capsule three times per day to be taken between meals in the absence of any animal fats.

The Moducare® mixture has been shown to have immune modulating properties. It has been shown, both in vitro as well as in vivo, to have the following immunological activities:

• Enhances the cellular division of peripheral blood lymphocytes when these are activated by stimuli [1];
• Enhances the killing ability/cytotoxicity of specialized cells responsible for immune surveillance, namely the Natural Killer cells
  (NK cells) [1];
• Enhances the ability of T lymphocytes to release the factors that ultimately regulate cellular functions in the body. These T cells
  (T_H1 helper cells) are antagonist to the activity of other helper cells (T_H2) that promote the functions of B lymphocytes [2];
• The mixture of sterols/sterolins has anti-inflammatory properties by switching off the release of pro-inflammatory factors such as Interleukin 6 (IL6) and Tumor Necrosis Factor-alpha (TNF-) from activated monocytes [3];
• Increases the secretion of IL12, the cytokine released from antigen-presenting cells that promotes the differentiation of precursor T-helper cells into the more polarized T_H1 cells;
• The mixture has adreno-cortical effects by decreasing the cortisol:DHEA ratio suggestive that it enhances the synthesis of DHEA which ultimately, decreases the release of cortisol [4].

Numerous clinical studies have shown the efficacy of plant sterols/sterolins in vivo. Based on the biological activities described above, most studies to date have investigated the ability of Moducare® to control inflammation or induce a shift from a predominantly humoral immune response to a more protective cellular response (i.e. T_H2 to T_H1 shift). Therefore, studies have been conducted in several infectious diseases as well as chronic inflammatory conditions and in models of immune stress. Briefly, these include:

• The investigation of Moducare® as adjuvants in the treatment of pulmonary tuberculosis. This double-blind, placebo-controlled study showed that patients having received the capsules containing the sterols/sterolins had less inflammation, recovered from the mycobacterial infection faster (faster resolution of lung lesions) and recovered their immunological status faster [5]. Other markers of efficacy included higher weight gain. All patients had received standard anti-tuberculosis therapy.
• The sterols/sterolins mixture was tested in a clinical study (double-blind, placebo-controlled) conducted in marathon runners, a model of the effects of excessive exercise on the immune system. Such individuals are prone to transient immune suppression due to the activation of several endocrinological shifts that ultimately lead to decreased immunity. This study showed that the marathon runners had less inflammation post event (lower IL6 plasma levels), less haematological disturbances (less lymphopaenia and less neutrophilia in the peripheral blood) and maintained their adreno-cortical status compared to their baseline values [6]. The study thus showed that Moducare® was able to abrogate the immunological shifts that usually accompany endurance exercise.
• The use of the mixture by HIV-infected individuals has been extensively studied [7]. It has been shown to prevent the decline of CD4 cell numbers (a surrogate marker of disease progression), decrease the plasma viral loads of patients and maintain a relatively intact immune profile despite the chronic viral infection. This implies that the use of the immune modulator by HIV-infected individuals would prevent the deterioration of the immunity and the maintenance of effective cellular responses to the virus [8].
• In a clinical model of chronic inflammation, Rheumatoid arthritis patients were followed over a period of 6 months and this study (double-blind, placebo-controlled) showed attenuation of indices of disease activity due to the potent anti-inflammatory properties of the sterols/sterolins [9].
• In an open-labeled study, allergic rhinitis and sinusitis patients were followed over a period of 12 weeks and again, the degree of allergic responses showed significant changes accompanied by clinical improvement and symptomatic relief of patients. Markers of efficacy included decrease in serum IgE levels, decrease in the T_H2 cell activity, less turbinate hypertrophy and rhinonorea, etc [10].

To date, no drug-drug interactions have been observed in patients using Moducare®. It is advisable for patients to inform their clinicians of their intention to use this supplement. It has to be understood that it does not replace conventional medication, especially those used for life-threatening diseases. Moducare® should be viewed as an adjunct to help shift the immune responses to a more balanced status and to control chronic inflammation.

At present, patients having received solid organ or tissue transplants should avoid the use of this immune modulator. This is based on the ability of the sterols/sterolins in the current formulation to promote cellular immune mechanisms, the same mechanisms being responsible for graft rejection.

Patrick J.D. Bouic, Ph.D., August 2002

References:

 

1. Bouic PJD et al (1996): Int. J. Immunopharmacol. 18, 693-700.
2. Bouic PJD & Lamprecht JH (1999): Alt. Med. Rev. 4, 170-177.
3. Bouic PJD (2001): Curr. Opin. Clin. Nutr. Metab. Care 4, 471-475.
4. Bouic PJD (2002): Drug Disc. Today 7, 775-778.
5. Donald PR et al (1997): Int. J. Tuberc. Lung Dis. 1, 518-522.
6. Bouic PJD et al (1999): Int. J. Sports Med. 20, 258-262.
7. Bouic PJD et al (2001): S.Afr. Med. J. 91, 848-850.
8. Breytenbach U. et al (2001): Cell Biol. Int. 25, 43-49.
9. Louw I. et al (2002): Am. J. Clin. Nutr. 75, Abstract 40, 351S
10. Myers L. et al (1998): Abstract in Proc. 26th Annu Cong Physiol. Soc. S. Afr. [Abstract 178].