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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Bricia López-Plaza - , La Paz University Hospital Institute for Health Research (IdiPAZ) (Autor:in)
  • Ángel Gil - , University of Granada (Autor:in)
  • Adrián Menéndez-Rey - , Medicinal Gardens S.L. (Autor:in)
  • Loan Bensadon-Naeder - , Medicinal Gardens S.L. (Autor:in)
  • Thomas Hummel - , Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Jaime Feliú-Batlle - , La Paz University Hospital Institute for Health Research (IdiPAZ) (Autor:in)
  • Samara Palma-Milla - , Autonomous University of Madrid (Autor:in)

Abstract

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 Synsepalum dulcificum (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).

Details

OriginalspracheEnglisch
Aufsatznummer4639
FachzeitschriftNutrients
Jahrgang15
Ausgabenummer21
PublikationsstatusVeröffentlicht - 1 Nov. 2023
Peer-Review-StatusJa

Externe IDs

PubMedCentral PMC10648678
Scopus 85176565984
ORCID /0000-0001-9713-0183/work/147674827

Schlagworte

Schlagwörter

  • Humans, Taste Perception, Taste, Pilot Projects, Nutritional Status, Quality of Life, Fruit/metabolism, Neoplasms/metabolism, Dietary Supplements, Malnutrition/etiology, Randomized Controlled Trials as Topic