Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol
Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition leads to reduced food consumption, increasing the risk of malnutrition. Malnutrition is associated not only with worse treatment effica...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-11-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/15/21/4639 |
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| author | Bricia López-Plaza Ángel Gil Adrián Menéndez-Rey Loan Bensadon-Naeder Thomas Hummel Jaime Feliú-Batlle Samara Palma-Milla |
| author_facet | Bricia López-Plaza Ángel Gil Adrián Menéndez-Rey Loan Bensadon-Naeder Thomas Hummel Jaime Feliú-Batlle Samara Palma-Milla |
| author_sort | Bricia López-Plaza |
| collection | DOAJ |
| description | Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition leads to reduced food consumption, increasing the risk of malnutrition. Malnutrition is associated not only with worse treatment efficacy and poor disease prognosis but also with reduced functional status and quality of life. The fruit of <i>Synsepalum dulcificum</i> (Daniell), commonly known as miracle berry or miracle fruit, contains miraculin, a taste-modifying protein with profound effects on taste perception. The CLINMIR Protocol is a triple-blind, randomized, placebo-controlled clinical trial designed to evaluate the regular consumption of a food supplement containing a miraculin-based novel food, dried miracle berry (DMB), on the taste perception (measured through electrogustometry) and nutritional status (evaluated through the GLIM Criteria) of malnourished cancer patients under active antineoplastic treatment. To this end, a pilot study was designed with 30 randomized patients divided into three study arms (150 mg DMB + 150 mg freeze-dried strawberries, 300 mg DMB, or placebo) for three months. Throughout the five main visits, an exhaustive assessment of different parameters susceptible to improvement through regular consumption of the miraculin-based food supplement will be conducted, including electrical and chemical taste perception, smell perception, nutritional and morphofunctional assessment, diet, quality of life, the fatty acid profile of erythrocytes, levels of inflammatory and cancer-associated cytokines, oxidative stress, antioxidant defense system, plasma metabolomics, and saliva and stool microbiota. The primary anticipated result is that malnourished cancer patients with taste distortion who consume the miraculin-based food supplement will report an improvement in food taste perception. This improvement translates into increased food intake, thereby ameliorating their nutritional status and mitigating associated risks. Additionally, the study aims to pinpoint the optimal dosage that provides maximal benefits. The protocol adheres to the SPIRIT 2013 Statement, which provides evidence-based recommendations and is widely endorsed as an international standard for trial protocols. The clinical trial protocol has been registered at the platform for Clinical Trials (NCT05486260). |
| first_indexed | 2024-03-11T11:23:27Z |
| format | Article |
| id | doaj.art-715b081d8ff54ce79ae330f695cc59aa |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-11T11:23:27Z |
| publishDate | 2023-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-715b081d8ff54ce79ae330f695cc59aa2023-11-10T15:09:52ZengMDPI AGNutrients2072-66432023-11-011521463910.3390/nu15214639Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot ProtocolBricia López-Plaza0Ángel Gil1Adrián Menéndez-Rey2Loan Bensadon-Naeder3Thomas Hummel4Jaime Feliú-Batlle5Samara Palma-Milla6Nutrition Research Group, La Paz University Hospital Institute for Health Research (IdiPAZ), 28046 Madrid, SpainDepartment of Biochemistry and Molecular Biology II, University of Granada, 18071 Granada, SpainMedicinal Gardens S.L., 28008 Madrid, SpainMedicinal Gardens S.L., 28008 Madrid, SpainSmell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Fetscherstraße 74, 01307 Dresden, GermanyOncology Department, Hospital La Paz Institute for Health Research—IdiPAZ, Hospital Universitario La Paz, 28029 Madrid, SpainMedicine Department, Faculty of Medicine, Autonomous University of Madrid, Arzobispo Morcillo 4, 28029 Madrid, SpainTaste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition leads to reduced food consumption, increasing the risk of malnutrition. Malnutrition is associated not only with worse treatment efficacy and poor disease prognosis but also with reduced functional status and quality of life. The fruit of <i>Synsepalum dulcificum</i> (Daniell), commonly known as miracle berry or miracle fruit, contains miraculin, a taste-modifying protein with profound effects on taste perception. The CLINMIR Protocol is a triple-blind, randomized, placebo-controlled clinical trial designed to evaluate the regular consumption of a food supplement containing a miraculin-based novel food, dried miracle berry (DMB), on the taste perception (measured through electrogustometry) and nutritional status (evaluated through the GLIM Criteria) of malnourished cancer patients under active antineoplastic treatment. To this end, a pilot study was designed with 30 randomized patients divided into three study arms (150 mg DMB + 150 mg freeze-dried strawberries, 300 mg DMB, or placebo) for three months. Throughout the five main visits, an exhaustive assessment of different parameters susceptible to improvement through regular consumption of the miraculin-based food supplement will be conducted, including electrical and chemical taste perception, smell perception, nutritional and morphofunctional assessment, diet, quality of life, the fatty acid profile of erythrocytes, levels of inflammatory and cancer-associated cytokines, oxidative stress, antioxidant defense system, plasma metabolomics, and saliva and stool microbiota. The primary anticipated result is that malnourished cancer patients with taste distortion who consume the miraculin-based food supplement will report an improvement in food taste perception. This improvement translates into increased food intake, thereby ameliorating their nutritional status and mitigating associated risks. Additionally, the study aims to pinpoint the optimal dosage that provides maximal benefits. The protocol adheres to the SPIRIT 2013 Statement, which provides evidence-based recommendations and is widely endorsed as an international standard for trial protocols. The clinical trial protocol has been registered at the platform for Clinical Trials (NCT05486260).https://www.mdpi.com/2072-6643/15/21/4639taste disordersdysgeusianeoplasmchemotherapy<i>Synsepalum ducificum</i>miracle fruit |
| spellingShingle | Bricia López-Plaza Ángel Gil Adrián Menéndez-Rey Loan Bensadon-Naeder Thomas Hummel Jaime Feliú-Batlle Samara Palma-Milla Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol Nutrients taste disorders dysgeusia neoplasm chemotherapy <i>Synsepalum ducificum</i> miracle fruit |
| title | Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol |
| title_full | Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol |
| title_fullStr | Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol |
| title_full_unstemmed | Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol |
| title_short | Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol |
| title_sort | effect of regular consumption of a miraculin based food supplement on taste perception and nutritional status in malnourished cancer patients a triple blind randomized placebo controlled clinical trial clinmir pilot protocol |
| topic | taste disorders dysgeusia neoplasm chemotherapy <i>Synsepalum ducificum</i> miracle fruit |
| url | https://www.mdpi.com/2072-6643/15/21/4639 |
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