Efficacy and Safety of Habitual Consumption of a Food Supplement Containing Miraculin in Malnourished Cancer Patients: The CLINMIR Pilot Study

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Bricia López-Plaza - , Universidad Autónoma de Madrid, Complutense University (Autor:in)
  • Ana Isabel Álvarez-Mercado - , University of Granada, Hospital Universitario Virgen de las Nieves (Autor:in)
  • Lucía Arcos-Castellanos - , Universidad Autónoma de Madrid (Autor:in)
  • Julio Plaza-Diaz - , Hospital Universitario Virgen de las Nieves, University of Granada, University of Ottawa (Autor:in)
  • Francisco Javier Ruiz-Ojeda - , Hospital Universitario Virgen de las Nieves, University of Granada, CIBER - Centro de Investigación Biomédica en Red (Autor:in)
  • Marco Brandimonte-Hernández - , University of Granada (Autor:in)
  • Jaime Feliú-Batlle - , Universidad Autónoma de Madrid, Instituto de Salud Carlos III (Autor:in)
  • Thomas Hummel - , Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Ángel Gil - , Hospital Universitario Virgen de las Nieves, University of Granada, CIBER - Centro de Investigación Biomédica en Red (Autor:in)
  • Samara Palma-Milla - , Universidad Autónoma de Madrid, Hospital Universitario La Paz (Autor:in)

Abstract

Taste disorders (TDs) are common among systemically treated cancer patients and negatively impact their nutritional status and quality of life. The novel food approved by the European Commission (EFSA), dried miracle berries (DMB), contains the natural taste-modifying protein miraculin. DMB, also available as a supplement, has emerged as a possible alternative treatment for TDs. The present study aimed to evaluate the efficacy and safety of habitual DMB consumption in malnourished cancer patients undergoing active treatment. An exploratory clinical trial was carried out in which 31 cancer patients 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 tablet or placebo daily before each main meal (breakfast, lunch, and dinner). Throughout the five main visits, electrochemical taste perception, nutritional status, dietary intake, quality of life and the fatty acid profile of erythrocytes were evaluated. Patients consuming a standard dose of DMB exhibited improved taste acuity over time (% change right/left side: -52.8 ± 38.5/-58.7 ± 69.2%) and salty taste perception (2.29 ± 1.25 vs. high dose: 2.17 ± 1.84 vs. placebo: 1.57 ± 1.51 points, p < 0.05). They also had higher energy intake (p = 0.075) and covered better energy expenditure (107 ± 19%). The quality of life evaluated by symptom scales improved in patients receiving the standard dose of DMB (constipation, p = 0.048). The levels of arachidonic (13.1 ± 1.8; 14.0 ± 2.8, 12.0 ± 2.0%; p = 0.004) and docosahexaenoic (4.4 ± 1.7; 4.1 ± 1.0; 3.9 ± 1.6%; p = 0.014) acids in erythrocytes increased over time after DMB intake. The standard dose of DMB increased fat-free mass vs. placebo (47.4 ± 9.3 vs. 44.1 ± 4.7 kg, p = 0.007). Importantly, habitual patients with DMB did not experience any adverse events, and metabolic parameters remained stable and within normal ranges. In conclusion, habitual consumption of a standard 150 mg dose of DMB improves electrochemical food perception, nutritional status (energy intake, fat quantity and quality, fat-free mass), and quality of life in malnourished cancer patients receiving antineoplastic treatment. Additionally, DMB consumption appears to be safe, with no changes in major biochemical parameters associated with health status. Clinical trial registered (NCT05486260).

Details

OriginalspracheEnglisch
Aufsatznummer1905
Seitenumfang26
FachzeitschriftNutrients
Jahrgang16 (2024)
Ausgabenummer12
PublikationsstatusVeröffentlicht - 17 Juni 2024
Peer-Review-StatusJa

Externe IDs

PubMed 38931260
ORCID /0000-0001-9713-0183/work/163766503

Schlagworte

Schlagwörter

  • Synsepalum dulcificum, ageusia, chemotherapy, dysgeusia, fatty acids, malnutrition, miracle berry, miraculin protein, neoplasm, radiotherapy, taste disorders

Bibliotheksschlagworte