Clinical Studies

IMMUNE PARAMETERS STUDY – CELT NATURALS IMMUNO-CARE^®

CONDUCTED AT THE UNIVERSITY OF GUELPH, BY THE HUMAN NUTRACEUTICAL RESEARCH UNIT

The following randomized, double-blind, placebo-controlled clinical trial involving 20 subjects over 28 days, demonstrated that Immuno-Care^®, by Celt Naturals, Calgary, Canada, can have a beneficial effect on immune parameters. The clinical trial showed a reduction in basophils that release histamine, typically found in allergic reactions. We are pleased to provide the findings of this important trial and encourage you to contact Celt Naturals.

The Supplement Immuno-Care^® by Celt Naturals

Human Nutraceutical Research Unit, J.T. Powell Building. University of Guelph, Guelph,
Ontario, Canada N1G 2W1, Tel: (519) 824-4120, Ext. 5374, Fax: (519) 823-5247
Website: www.uoguelph.ca/hnru, Maggie Laidlaw, M.Sc., Interim Director, HNRU.

OBJECTIVE:

This trial was to determine the effects of the supplement Immuno-Care^®, by Celt Naturals, Calgary, Canada, containing plant sterols, pine bark antioxidants, and an essential fatty acid complex, on specific immune parameters and cardiovascular indices. The trial was conducted at the University of Guelph as a randomized, double-blind, placebo-controlled clinical trial, with 20 subjects over 28 days.

ABSTRACT

A randomized, double-blind, placebo-controlled clinical trial to determine the effects of Celt Naturals Immuno-Care^® supplement (containing plant sterols, pine bark antioxidants and essential fatty acid complex) on specific immune parameters and cardiovascular indices in both men and women with non-food allergies.

The supplement appears to have effect on immune parameters, particularly basophils and Il-6 levels. Given these results, this supplement would appear to have the potential to substantially alleviate allergic responses.

The supplement also significantly reduced circulating levels of LDL cholesterol and increased circulating levels of HDL cholesterol. There was a significant decrease in the ratio of TC/HDL, and in the ratio of LDL/HDL cholesterol, which corresponds to a decrease in cardiovascular risk, as these ratios are markers for a reduction in the risk for developing atherosclerosis.

This information is provided for educational purposes only and should not be construed as medical advice. Any reader requiring medical advice is strongly advised to consult a licensed healthcare professional. Any products mentioned are not intended to diagnose, treat, cure, mitigate, or prevent any disease. These statements have not been evaluated by the United States Food and Drug Administration (USFDA).

RESULTS

Immune Parameters

The effects of the supplement on immune parameters are presented in Table 1. A number of studies support the belief that human basophils play an important role in allergic inflammation. Mast cells and basophils express the high affinity receptor for IgE (FcepsilonRI) and play a central role for IgE-associated immediate hypersensitivity reactions and allergic disorders. During allergic reactions, basophils migrate from the blood compartment to inflammatory sites, where they act as effector cells, in concert with eosinophils. Basophils release histamine during inflammation and allergic reactions.

Table 1:

**Statistically significant, p<0.0.

The participants in the treatment group, when compared to the control group, showed a significant reduction in basophil count, while the reduction seen in the control group was non-significant.
A reduction in basophil count may indicate a reduction in histamine release.

The immune system also responds to stressors by causing certain immune cells to secrete the
pro-inflammatory cytokines, Interleukin-1 (IL-1) and Interleukin-6 (IL-6). These cytokines are both involved in inflammation, and IL-6, in particular, is thought to worsen the symptoms of autoimmune diseases and fibromyalgia.

IL-6 has been found to act as a growth factor in several tumors, and some viruses also use IL-6 to replicate. IL-6 also causes calcium to be released from bone, promoting osteoporosis. We must control the release of these cytokines if we want to enhance immunity and reduce degenerative diseases.

It was noted in the pilot trial that the pro-inflammatory cytokine IL-6 levels showed a substantial reduction in the treated group, when compared to the control group. Although the drop in the
IL-6 levels in the treatment group was not statistically significant, a larger study with more subjects, over a longer period of time, may show significance.

Celt Naturals Immuno-Care^® has demonstrated that it has an effect on histamine-containing basophil counts, with a reduction of IL-6 levels, and consequently may substantially alleviate symptoms associated with airborne allergens, asthma, and allergic rhinitis. Further studies are recommended, with a larger patient participation and a longer trial period, to investigate other areas of immunological response.

Cardiovascular Parameters

The effects of the supplement on lipid and lipoprotein parameters and cardiovascular indices are illustrated in Tables 2 and 3.

Table 2: The effects of Celt Immuno-Care^® on blood lipid parameters in experimental and placebo groups from Day 0 to Day 28.

**Statistically significant, p<0.05.

Table 3: The effects of Celt Immuno-Care^® supplementation on specific cardiovascular ratios in experimental and placebo groups from Day 0 to Day 28.

**Statistically significant, p<0.05.

The specific objective of this portion of the trial was to determine the effects of the supplement Celt Immuno-Care^® on blood lipid parameters. Significant reduction was noted in the overall LDL levels of the treatment group from day 0 to day 28. Perhaps what is more interesting is the increase, though not statistically significant, in HDL levels, compared with a relative decrease in the placebo group.

However, it is the ratios of various lipids and lipid proteins, rather than the absolute values, that are important in assessing cardiovascular risk, and consequently, these ratios were calculated and tabulated.

A significant decrease in the ratio of TC/HDL, and in the ratio of LDL/HDL cholesterol, was noted in the Celt Immuno-Care^® group. A decrease in these ratios corresponds to an associated decrease in the risk of cardiovascular disease (CVD). These ratios are markers for a reduction in the risk of developing atherosclerosis.

Consequently, it is our opinion that these results indicate that Celt Immuno-Care^® could be very beneficial to the health of hypercholesterolemic individuals at risk of developing CVD.

CONCLUSIONS

Celt Naturals Immuno-Care^® and its components appears to have an effect on immune parameters, particularly on basophils and possibly Interleukin-6 levels. Given these changes, Immuno-Care^® would appear to have the potential to substantially alleviate allergic responses.

Celt Immuno-Care^® could also have an effect on autoimmune diseases, such as Crohn’s disease or rheumatoid arthritis, or in the ability of subjects to resist the common cold virus, although studies on these particular populations would be required to verify possible beneficial effects.

This study verified that Celt Naturals Immuno-Care^® supplement is effective in reducing circulating levels of LDL cholesterol and increasing circulating levels of HDL cholesterol.

It is of interest to note that there was a significant decrease in the ratio of TC/HDL and LDL/HDL cholesterol in the Immuno-Care^® group. A decrease in these ratios corresponds to an associated decrease in risk of cardiovascular disease (CVD) as these ratios are markers for a reduction in the risk of developing atherosclerosis. Consequently, these results would be of considerable benefit to the health of hypercholesterolemic individuals at risk of developing CVD.