I don't think that I've posted this before. It's from KClM - a company that's producing soy kefir products. Two small trials indicated benefits - if you took enough of their grains - in ME/CFS/FM patients.
I must say though that their explanation of the benefits seem kind of strange to me; it focused on the efficacy of soy rather than the effects of the bacteria?
They are available for questions; if anyone has any questions that they would like asked let me know - I'm going to send some in.
I must say though that their explanation of the benefits seem kind of strange to me; it focused on the efficacy of soy rather than the effects of the bacteria?
They are available for questions; if anyone has any questions that they would like asked let me know - I'm going to send some in.
Soy Kefir – A Novel Functional Food Product with Implications for Chronic Fatigue Syndrome and Fibromyalgia
Soy Kefir product (SKP) is a dry concentrated form of soy kefir drink produced by a patent-pending fermentation process using kefir grains newly developed by KCLM Innovation which was founded at McGill University. Soy Kefir is made by adding kefir grains to liquid based soy. The kefir grains are soft white gelatinous masses which resemble small cauliflower florets containing clusters of bioactive microorganisms held together by Kefiran, a complex polysaccharide or sugar. The grains when added to soy will ferment and incorporate its bioactive microorganisms to create a cultured beverage with a variety of health benefits. It is therefore likely that a combination of biofactors involving Kefir fermentation by-products are involved in the beneficial health effects.
SKP is formulated to concentrate the bioactive components of kefir into an easily consumable form excluding any live bacteria or yeasts due to a heat-inactivation process used in its manufacturing. SKP has shown remarkable improvements in clinical studies in individuals suffering from both pain and fatigue.
Moreover, a double-blinded randomized controlled clinical trial (Ethica Inc.) performed to assess the safety of SKP in humans showed no adverse reactions as was determined by examination of routine blood serum chemistry. In addition, there were also no notable adverse events in heart rate and body weight. Although, some mild adverse GI events were noted which were nevertheless in a range of incidences commonly noted in such studies which generally show initial higher incidences of mild GI upset that usually dissipate.
Two separate clinical trials have tested the efficacy of SKP in patients with either Chronic Fatigue Syndrome or in patients with either Chronic Fatigue Syndrome or Fibromyalgia evaluated for 30 and 60 days. Reported benefits included amongst others; increased energy and vitality levels, significant pain relief and improved physical and emotional well-being.
Both clinical trials utilized a widely-used and highly validated FDA approved health status survey tool known as the SF-36v2 Health Survey. The survey assesses eight health concepts: physical functioning (PF) which defines limitation in physical activities, limitation in role activities (RP); bodily pain (BP), limitation in social activities (SF), general mental health (MH), limitation in usual role activities due to emotional problems (RE), vitality (energy and fatigue) (VT); and general health perception (GH). Scores for people at the top or bottom of a scale can be interpreted by looking at the items and response choices. For example, a person scoring at the bottom of the PF scale is very limited in all activities including bathing and dressing. The survey primarily measures physical and mental health.
Initially, a study was carried out to test the tolerance and effects of the product on a small group of patients. Eleven patients received 56 pouches of 17.5 grams of product, to be taken as 1 pouch twice a day for 4 weeks. Patients answered the SF-36v2 Health Survey questionnaire before and after the 4-week treatment period. Two patients however had to discontinue the treatment due to minor GI discomfort. However, the first patient said she had never felt so energetic since her ailment began.
Moreover, she suggested that she wanted to continue the product for 1 or 2 days a week, as her improvements were remarkable. Increased satiety effects were also noted after the ingestion of the product. All other patients took the Soy Kefir product for 4 weeks. For the statistical analysis, a two-tailed Wilcoxon test was used. The results of the questionnaire were assembled into 8 scales and the average score for each scale before and after the treatment were compared.
The first clinical trial conducted involving chronic fatigue subjects showed significant improvements (alpha risk < 5%) in a variety of parameters tested following a four-week intervention, including improvement in energy levels (VT), bodily pain (BP), energy and mood. Vitality was particularly improved. Anecdotally, three patients with chronic fatigue syndrome have now been taking SKP for over 3 years and feel that they cannot endure without the product. For two of the patients, the SKP is very important for pain relief whereas for the other single patient, the SKP is essential for vitality.
In the second trial, patients suffering with moderate intensity from chronic fatigue syndrome and fibromyalgia were recruited with symptoms of fatigue and widespread muscle and joint pain. Patients were followed for 60 days and SF-36v2 questionnaires were filled at baseline, after 30 and 60 days of treatment. A total of 27 patients completed the study with patients taking either 20g or 30 g of SKP. Statistical analysis aimed at comparing treatment groups at any time point to their baseline values by use of a two-tailed paired t-test. The study appeared to show a time and dose relationship to the SKP regimen. No statistically significant change occurred at 30 days with the 20 g dose with only scales of bodily pain and physical function showing a tendency to improve. However, with the 30 g dose after a 30-day intake, all scores had improvements greater than baseline. Statistically significant effects were observed for bodily pain, role physical and role emotional, with major improvement in scores.
At 60 days of treatment, the 20 g dose for the first time showed statistical improvements over baseline in physical function, role physical and bodily pain. Vitality showed a non-statistical improvement with the 20 g dose. The 30 g dose at 60 days showed similar findings that were observed at 30 days, with all scores statistically increased over baseline values in role physical, bodily pain, role emotional, and vitality scores. The study thus indicated that greater efficacy was observed with the 30 g vs. 20 g dose although improvements were noted in the 20 g dosage with greater length of treatment. Major clinically relevant increases in scores were nevertheless maintained over a more prolonged 60-day period of intake signifying no major diminution of effect.
The mechanisms of action for both pain and energy improvement with SKP are unclear but are likely multi-factorial. With respect to pain, a variety of studies indicate that a soy diet may reduce neuropathic pain in an animal model of partial nerve injury produced by tightly ligating 1/3–1/2 of the sciatic nerve 57 (PSL model) (Shir et al., 2001). The beneficial effects of soy protein on PSL may be related to the reduction in inflammation. Inflammation may contribute to chronic pain states such as neuropathic pain, as proinflammatory cytokines and oxidants produced at the site of nerve injury may be involved with sensitization of nociceptors and hyperalgesia (Wagner et al., 1998).
Neuropathic pain behaviors are reduced with anti-cytokine treatment (Wagner et al., 1998). Dietary consumption of soy protein isolate significantly reduces the carrageenan-induced production of TNF-alpha in macrophages (Yagasaki et al., 2001) and decreases the degree of edema and thermal hyperalgesia following injection of complete Freund's adjuvant (Tall and Raja, 2002).
Recent rat studies have also shown pain relief from thermal hyperalgesia following consumption a combination of soy lipids that was enhanced by intake of soy protein (Perez et al., 2004). Soy lipids have also been implicated in pain relief as rats fed soybean oil had an elevated pain threshold (Yehuda et al., 1986). Other bioactive components in soy could include isoflavones such as genistein that possess anti-inflammatory properties (Sadowska-Krowicka et al., 1998). Genistein has also been shown to inhibit lipopolysaccharide-induced production of the proinflammatory cytokines TNF-alpha, IL-1 alpha, and IL-6 in mixed glia, microglia- or astrocyte-enriched cultures (Kong et al., 1997). Another potential bioactive component is the soluble unique kefir polysaccharide, kefiran, as a recent study has indicated that oral intake of kefir grains induce anti-inflammatory effects in rats (Diniz et al., 2003).
The mechanisms of action with respect to energy improvement are also unclear but are also believed to be multifactorial. Chronic fatigue syndrome has been associated with higher serum angiotensin-converting enzyme (ACE) levels, which has been suggested to reflect damage to the vascular endothelium (Lieberman and Bell, 1993). Hence, a part of the efficacy of SKP in chronic fatigue might be related to its demonstrated ACE inhibitory activity (unpublished data), which has been well demonstrated for other fermented soy products (Kinoshita et al., 1993).
Several supplementation trials have indicated that branched chain amino acids (BCAA) can contribute to combat fatigue and to improve mental and physical performance in athletes (De Lorenzo et al., 2003; Blomstrand et al., 1997). Soy protein is one of the best sources of BCAA and fermentation increases the quantity of soluble proteins. Hence, the digestibility and bioavailability of BCAA from soy kefir would be significantly enhanced to provide a significant enhancement in BCAA uptake.
Amongst the bioactive ingredients in SKP are substantial amounts of isoflavones which have been shown to decrease inflammation, which has been indicated to play an important role for inducing fatigue (Collado-Hidalgo et al., 2006). Maintenance of effective plasma isoflavone concentrations can be achieved with regular daily consumption of SKP. In addition, soy kefir likely contains a host of components that may be involved in the medicinal effects including polyphenolic compounds as well as other bioactive molecules, which might exert cumulative biological effects.
In conclusion, clinically significant improvements in chronic fatigue syndrome patients and fibromyalgia with the soy-derived SKP product is an exciting new approach for treatment of the fatigue associated with this group of patients, particularly since no effective treatment exists by conventional medicine.
Soy Kefir product (SKP) is a dry concentrated form of soy kefir drink produced by a patent-pending fermentation process using kefir grains newly developed by KCLM Innovation which was founded at McGill University. Soy Kefir is made by adding kefir grains to liquid based soy. The kefir grains are soft white gelatinous masses which resemble small cauliflower florets containing clusters of bioactive microorganisms held together by Kefiran, a complex polysaccharide or sugar. The grains when added to soy will ferment and incorporate its bioactive microorganisms to create a cultured beverage with a variety of health benefits. It is therefore likely that a combination of biofactors involving Kefir fermentation by-products are involved in the beneficial health effects.
SKP is formulated to concentrate the bioactive components of kefir into an easily consumable form excluding any live bacteria or yeasts due to a heat-inactivation process used in its manufacturing. SKP has shown remarkable improvements in clinical studies in individuals suffering from both pain and fatigue.
Moreover, a double-blinded randomized controlled clinical trial (Ethica Inc.) performed to assess the safety of SKP in humans showed no adverse reactions as was determined by examination of routine blood serum chemistry. In addition, there were also no notable adverse events in heart rate and body weight. Although, some mild adverse GI events were noted which were nevertheless in a range of incidences commonly noted in such studies which generally show initial higher incidences of mild GI upset that usually dissipate.
Two separate clinical trials have tested the efficacy of SKP in patients with either Chronic Fatigue Syndrome or in patients with either Chronic Fatigue Syndrome or Fibromyalgia evaluated for 30 and 60 days. Reported benefits included amongst others; increased energy and vitality levels, significant pain relief and improved physical and emotional well-being.
Both clinical trials utilized a widely-used and highly validated FDA approved health status survey tool known as the SF-36v2 Health Survey. The survey assesses eight health concepts: physical functioning (PF) which defines limitation in physical activities, limitation in role activities (RP); bodily pain (BP), limitation in social activities (SF), general mental health (MH), limitation in usual role activities due to emotional problems (RE), vitality (energy and fatigue) (VT); and general health perception (GH). Scores for people at the top or bottom of a scale can be interpreted by looking at the items and response choices. For example, a person scoring at the bottom of the PF scale is very limited in all activities including bathing and dressing. The survey primarily measures physical and mental health.
Initially, a study was carried out to test the tolerance and effects of the product on a small group of patients. Eleven patients received 56 pouches of 17.5 grams of product, to be taken as 1 pouch twice a day for 4 weeks. Patients answered the SF-36v2 Health Survey questionnaire before and after the 4-week treatment period. Two patients however had to discontinue the treatment due to minor GI discomfort. However, the first patient said she had never felt so energetic since her ailment began.
Moreover, she suggested that she wanted to continue the product for 1 or 2 days a week, as her improvements were remarkable. Increased satiety effects were also noted after the ingestion of the product. All other patients took the Soy Kefir product for 4 weeks. For the statistical analysis, a two-tailed Wilcoxon test was used. The results of the questionnaire were assembled into 8 scales and the average score for each scale before and after the treatment were compared.
The first clinical trial conducted involving chronic fatigue subjects showed significant improvements (alpha risk < 5%) in a variety of parameters tested following a four-week intervention, including improvement in energy levels (VT), bodily pain (BP), energy and mood. Vitality was particularly improved. Anecdotally, three patients with chronic fatigue syndrome have now been taking SKP for over 3 years and feel that they cannot endure without the product. For two of the patients, the SKP is very important for pain relief whereas for the other single patient, the SKP is essential for vitality.
In the second trial, patients suffering with moderate intensity from chronic fatigue syndrome and fibromyalgia were recruited with symptoms of fatigue and widespread muscle and joint pain. Patients were followed for 60 days and SF-36v2 questionnaires were filled at baseline, after 30 and 60 days of treatment. A total of 27 patients completed the study with patients taking either 20g or 30 g of SKP. Statistical analysis aimed at comparing treatment groups at any time point to their baseline values by use of a two-tailed paired t-test. The study appeared to show a time and dose relationship to the SKP regimen. No statistically significant change occurred at 30 days with the 20 g dose with only scales of bodily pain and physical function showing a tendency to improve. However, with the 30 g dose after a 30-day intake, all scores had improvements greater than baseline. Statistically significant effects were observed for bodily pain, role physical and role emotional, with major improvement in scores.
At 60 days of treatment, the 20 g dose for the first time showed statistical improvements over baseline in physical function, role physical and bodily pain. Vitality showed a non-statistical improvement with the 20 g dose. The 30 g dose at 60 days showed similar findings that were observed at 30 days, with all scores statistically increased over baseline values in role physical, bodily pain, role emotional, and vitality scores. The study thus indicated that greater efficacy was observed with the 30 g vs. 20 g dose although improvements were noted in the 20 g dosage with greater length of treatment. Major clinically relevant increases in scores were nevertheless maintained over a more prolonged 60-day period of intake signifying no major diminution of effect.
The mechanisms of action for both pain and energy improvement with SKP are unclear but are likely multi-factorial. With respect to pain, a variety of studies indicate that a soy diet may reduce neuropathic pain in an animal model of partial nerve injury produced by tightly ligating 1/3–1/2 of the sciatic nerve 57 (PSL model) (Shir et al., 2001). The beneficial effects of soy protein on PSL may be related to the reduction in inflammation. Inflammation may contribute to chronic pain states such as neuropathic pain, as proinflammatory cytokines and oxidants produced at the site of nerve injury may be involved with sensitization of nociceptors and hyperalgesia (Wagner et al., 1998).
Neuropathic pain behaviors are reduced with anti-cytokine treatment (Wagner et al., 1998). Dietary consumption of soy protein isolate significantly reduces the carrageenan-induced production of TNF-alpha in macrophages (Yagasaki et al., 2001) and decreases the degree of edema and thermal hyperalgesia following injection of complete Freund's adjuvant (Tall and Raja, 2002).
Recent rat studies have also shown pain relief from thermal hyperalgesia following consumption a combination of soy lipids that was enhanced by intake of soy protein (Perez et al., 2004). Soy lipids have also been implicated in pain relief as rats fed soybean oil had an elevated pain threshold (Yehuda et al., 1986). Other bioactive components in soy could include isoflavones such as genistein that possess anti-inflammatory properties (Sadowska-Krowicka et al., 1998). Genistein has also been shown to inhibit lipopolysaccharide-induced production of the proinflammatory cytokines TNF-alpha, IL-1 alpha, and IL-6 in mixed glia, microglia- or astrocyte-enriched cultures (Kong et al., 1997). Another potential bioactive component is the soluble unique kefir polysaccharide, kefiran, as a recent study has indicated that oral intake of kefir grains induce anti-inflammatory effects in rats (Diniz et al., 2003).
The mechanisms of action with respect to energy improvement are also unclear but are also believed to be multifactorial. Chronic fatigue syndrome has been associated with higher serum angiotensin-converting enzyme (ACE) levels, which has been suggested to reflect damage to the vascular endothelium (Lieberman and Bell, 1993). Hence, a part of the efficacy of SKP in chronic fatigue might be related to its demonstrated ACE inhibitory activity (unpublished data), which has been well demonstrated for other fermented soy products (Kinoshita et al., 1993).
Several supplementation trials have indicated that branched chain amino acids (BCAA) can contribute to combat fatigue and to improve mental and physical performance in athletes (De Lorenzo et al., 2003; Blomstrand et al., 1997). Soy protein is one of the best sources of BCAA and fermentation increases the quantity of soluble proteins. Hence, the digestibility and bioavailability of BCAA from soy kefir would be significantly enhanced to provide a significant enhancement in BCAA uptake.
Amongst the bioactive ingredients in SKP are substantial amounts of isoflavones which have been shown to decrease inflammation, which has been indicated to play an important role for inducing fatigue (Collado-Hidalgo et al., 2006). Maintenance of effective plasma isoflavone concentrations can be achieved with regular daily consumption of SKP. In addition, soy kefir likely contains a host of components that may be involved in the medicinal effects including polyphenolic compounds as well as other bioactive molecules, which might exert cumulative biological effects.
In conclusion, clinically significant improvements in chronic fatigue syndrome patients and fibromyalgia with the soy-derived SKP product is an exciting new approach for treatment of the fatigue associated with this group of patients, particularly since no effective treatment exists by conventional medicine.