The Regular Consumption of a Food Supplement Containing Miraculin Can Contribute to Reducing Biomarkers of Inflammation and Cachexia in Malnourished Patients with Cancer and Taste Disorders: The CLINMIR Pilot Study
Abstract: BackgroundTaste disorders are common in patients with cancer undergoing systemic therapy, persist during treatment and are associated with reduced food intake, increasing the risk of malnutrition. Cachectic syndrome, which is common in these patients and characterized by marked weight loss, anorexia, asthenia and anemia, is linked to the presence and growth of the tumor and leads to systemic inflammation.Synsepalum dulcificumis a plant whose berries contain miraculin, a glycoprotein that transforms sour tastes… Show more
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Effect of a novel food rich in miraculin on the oral microbiome of malnourished oncologic patients with dysgeusia
Dysgeusia contributes to the derangement of nutritional status in patients with cancer, as well as worsening the quality of life. The pharmaceutical industry has failed to provide effective treatments for patients suffering from taste disorders. The present study provided a novel strategy to reduce side effects in patients with cancer through the administration of a novel food supplement approved by the European Union, Dried Miracle Berries (DMB), containing the taste-modifying glycoprotein miraculin, as an adjuvant to medical-nutritional treatment. This was done in a pilot randomized, parallel, triple-blind, and placebo-controlled intervention clinical trial in which 31 malnourished patients with cancer and dysgeusia receiving antineoplastic treatment were randomized into three arms [standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry)] for three months. Patients consumed a DMB or placebo tablet before each main meal. Using the Nanopore methodology, we analyzed the oral microbiome of patients with cancer using saliva samples. All patients with cancer and dysgeusia had dysbiosis in terms of lower bacterial diversity and richness. DMB consumption was associated with changes in oral microbiome composition. Neither selected bacteria, nor taste perception, type of diet, and cytokine levels were associated with mucositis. Likewise, alcohol and tobacco consumption as well as general and digestive toxicity due to systemic therapy was not associated to specific changes of the oral microbiota. The standard dose of DMB resulted in a greater relative abundance ofEnterococcusand a lower abundance ofVeillonellacompared with the high DMB dose and placebo. In particular, some species such asGranulicatella elegans,Granulicatella adiacens,Streptococcus mutans, andGemella morbillorumshowed higher relative abundances in the DMB standard-dose group; in contrast,Streptococcus parasanguinis,Veillonella parvula,Streptococcus australis, andStreptococcus cristatuswere less abundant. Additionally, the consumption of a standard dose of DMB revealed a negative association between the concentrations of TNF-α and the abundance of species such asStreptococcus thermophilus,Streptococcus pneumoniae,Streptococcus dysgalactiaeandStreptococcus agalactiae.Accordingly, regular DMB consumption changed the oral microbiome in patients with cancer and dysgeusia, which may contribute to maintaining an appropriate immune response without changing taste perception. However, as the present pilot study involved a small number of participants, further studies are necessary draw robust conclusions from the data.HighlightsPatients with cancer and dysgeusia exhibit a dysbiotic state in terms of bacterial diversity and richness.The regular consumption of a standard dose of Dried Miracle Berries (DMB), rich in miraculin, before each main meal for three months as an adjuvant to medical-nutritional treatment, improves the oral microbiome composition in malnourished patients with cancer and dysgeusia.Several species i.e.,Granulicatella elegans,Granulicatella adiacens,Streptococcus mutans, andGemella morbillorum, show higher relative abundances in the DMB standard-dose group; in contrast,Streptococcus parasanguinis,Veillonella parvula,Streptococcus australis, andStreptococcus cristatusare less abundantDMB consumption is negatively associated with some species ofStreptococcusand TNF-α concentrations in malnourished patients with cancer and dysgeusia.Neither of the highly represented bacteria are associated with the presence or absence of mucositis, digestive toxicity, or tobacco use and alcohol consumption or a change in taste perception at the end of the intervention.
Effect of a novel food rich in miraculin on the oral microbiome of malnourished oncologic patients with dysgeusia
Dysgeusia contributes to the derangement of nutritional status in patients with cancer, as well as worsening the quality of life. The pharmaceutical industry has failed to provide effective treatments for patients suffering from taste disorders. The present study provided a novel strategy to reduce side effects in patients with cancer through the administration of a novel food supplement approved by the European Union, Dried Miracle Berries (DMB), containing the taste-modifying glycoprotein miraculin, as an adjuvant to medical-nutritional treatment. This was done in a pilot randomized, parallel, triple-blind, and placebo-controlled intervention clinical trial in which 31 malnourished patients with cancer and dysgeusia receiving antineoplastic treatment were randomized into three arms [standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry)] for three months. Patients consumed a DMB or placebo tablet before each main meal. Using the Nanopore methodology, we analyzed the oral microbiome of patients with cancer using saliva samples. All patients with cancer and dysgeusia had dysbiosis in terms of lower bacterial diversity and richness. DMB consumption was associated with changes in oral microbiome composition. Neither selected bacteria, nor taste perception, type of diet, and cytokine levels were associated with mucositis. Likewise, alcohol and tobacco consumption as well as general and digestive toxicity due to systemic therapy was not associated to specific changes of the oral microbiota. The standard dose of DMB resulted in a greater relative abundance ofEnterococcusand a lower abundance ofVeillonellacompared with the high DMB dose and placebo. In particular, some species such asGranulicatella elegans,Granulicatella adiacens,Streptococcus mutans, andGemella morbillorumshowed higher relative abundances in the DMB standard-dose group; in contrast,Streptococcus parasanguinis,Veillonella parvula,Streptococcus australis, andStreptococcus cristatuswere less abundant. Additionally, the consumption of a standard dose of DMB revealed a negative association between the concentrations of TNF-α and the abundance of species such asStreptococcus thermophilus,Streptococcus pneumoniae,Streptococcus dysgalactiaeandStreptococcus agalactiae.Accordingly, regular DMB consumption changed the oral microbiome in patients with cancer and dysgeusia, which may contribute to maintaining an appropriate immune response without changing taste perception. However, as the present pilot study involved a small number of participants, further studies are necessary draw robust conclusions from the data.HighlightsPatients with cancer and dysgeusia exhibit a dysbiotic state in terms of bacterial diversity and richness.The regular consumption of a standard dose of Dried Miracle Berries (DMB), rich in miraculin, before each main meal for three months as an adjuvant to medical-nutritional treatment, improves the oral microbiome composition in malnourished patients with cancer and dysgeusia.Several species i.e.,Granulicatella elegans,Granulicatella adiacens,Streptococcus mutans, andGemella morbillorum, show higher relative abundances in the DMB standard-dose group; in contrast,Streptococcus parasanguinis,Veillonella parvula,Streptococcus australis, andStreptococcus cristatusare less abundantDMB consumption is negatively associated with some species ofStreptococcusand TNF-α concentrations in malnourished patients with cancer and dysgeusia.Neither of the highly represented bacteria are associated with the presence or absence of mucositis, digestive toxicity, or tobacco use and alcohol consumption or a change in taste perception at the end of the intervention.
Effect of a novel food rich in miraculin on the intestinal microbiome of malnourished patients with cancer and dysgeusia
Dysgeusia contributes to nutritional derangement and worsens the quality of life of patients with cancer. Despite the different strategies, there is no effective treatment for patients suffering from taste disorders provided by the pharmaceutical industry. We developed a novel strategy for reducing side effects in cancer patients by providing a novel food supplement with the tastemodifying glycoprotein miraculin, which is approved by the European Union, as an adjuvant to medical-nutritional therapy. A pilot randomized, parallel, triple-blind, and placebo-controlled intervention clinical trial was carried out in which 31 malnourished patients with cancer and dysgeusia receiving antineoplastic treatment, and were randomized into three arms: standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry) for three months. Patients consumed a DMB or placebo tablet before each main meal (breakfast, lunch and dinner). Using stool samples from patients with cancer, we analyzed the intestinal microbiome via nanopore methodology. We detected differences in the relative abundances of generaPhocaeicolaandEscherichiadepending on the treatment. Nevertheless, only theSolibaculumgenus was more abundant in the standard-dose DMB group after 3 months. At the species level,Bacteroidessp. PHL 2737 presented a relatively low abundance in both DMB groups, andVescimonas coprocolapresented a relatively high abundance in both treatment groups after 3 months. Furthermore, a standard dose of DMB was positively associated with TNF-α levels andLachnoclostridiumandMediterraneibacterabundances, whereas a high dose of DMB was negatively associated with TNF-α levels and the relative abundance ofPhocaeicola. After a high dose of DMB, erythrocyte polyunsaturated fatty acids were positively correlated withLachnoclostridiumandRoseburia, and there was a positive association betweenPhocaeicolaand the acetic acid concentration of feces. The intake of DMB together with nutritional treatment and individualized dietary advice results in positive changes in the intestinal microbiome of patients with cancer and dysgeusia There was a negative association between the relative abundance ofPhocaeicolaand taste perception in the DMB high dose group. Changes observed in the intestinal microbiota might contribute to maintaining an appropriate immune response of cancer patients. Since the present pilot study involved only a few participants, further research is needed to draw robust conclusions.
Effect of a Novel Food Rich in Miraculin on the Oral Microbiome of Malnourished Oncologic Patients with Dysgeusia
Background/Objectives: Dysgeusia contributes to the derangement of nutritional status in patients with cancer as well as worsening the quality of life. There has been a lack of effective treatments for taste disorders provided by the pharmaceutical industry. Methods: This was a pilot randomized, parallel, triple-blind, and placebo-controlled intervention clinical trial in which 31 malnourished patients with cancer and dysgeusia receiving antineoplastic treatment were randomized into three arms [standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry)] for three months. Patients consumed a DMB or placebo tablet before each main meal. Using the nanopore methodology, we analyzed the oral microbiome of patients with cancer using saliva samples. Results: All patients with cancer and dysgeusia had dysbiosis in terms of lower bacterial diversity and richness. DMB consumption was associated with changes in oral microbiome composition. Neither selected bacteria nor taste perception, type of diet, and cytokine levels were associated with mucositis. Likewise, alcohol and tobacco consumption as well as general and digestive toxicity due to systemic therapy were not associated with specific changes of the oral microbiome, according to logistic binary regression. The standard dose of DMB resulted in a lower abundance of Veillonella compared with the high DMB dose and placebo at 3 months after intervention with DMB. In particular, some species such as Streptococcus parasanguinis, Veillonella parvula, and Streptococcus mutans were less abundant in the DMB standard-dose group. Additionally, the consumption of a standard dose of DMB revealed a negative association between the concentrations of TNF-α and the abundance of species such as Streptococcus thermophilus, Streptococcus pneumoniae, Streptococcus dysgalactiae and Streptococcus agalactiae. Conclusions: Accordingly, regular DMB consumption could modify the oral microbiome in patients with cancer and dysgeusia, which may contribute to maintaining an appropriate immune response. However, as the present pilot study involved a small number of participants, further studies are necessary to draw robust conclusions from the data.
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