Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients

NCT05486260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-08-15

No results posted yet for this study

Summary

Cancer is one of the main causes of death globally, being in many countries the first cause of mortality. One of the main side effects of chemotherapy and/or radiotherapy treatment in cancer patients is the alteration of taste and smell, internationally known as these anomalies Taste Smell Alterations (TSA). These alterations are the result of an altered cellular structure, the presence of TSA is associated with reduced quality of life and poor nutrition, due to dietary changes made by these patients.

Synsepalum dulcidicum (dried miracle berry, DMB) is a plant belonging to the Sapotaceae family, made up of around 800 species grouped into around 40 genera. It is an indigenous species to the forest regions of West Africa. Nuts of this specie have been approved as a novel food in accordance with Regulation (EU) 2015/2238 and at the request of the European Commission through the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. The characteristic component of DMB is miraculin. Miraculin is a glycoprotein whose consumption causes acidic and sour foods, and to a lesser extent bitter, to be perceived as having a sweet taste. In this sense, it is possible that the consumption of DMB before each meal can improve sensory perception after treatment with chemotherapy or radiotherapy.

Conditions

  • Cancer
  • Dysgeusia
  • Hypogeusia
  • Ageusia
  • Chemotherapy Effect
  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

DMB lowest dose

Intake of 150 mg of DMB

DIETARY_SUPPLEMENT

DMB highest dose

Intake of 300 mg of DMB

DIETARY_SUPPLEMENT

Strawberry lyophilisate

Intake of 300 mg of strawberry lyophilisate

Sponsors & Collaborators

  • Instituto de Nutrición y Tecnología de los Alimentos

    collaborator OTHER
  • Medicinal Gardens S.L

    collaborator UNKNOWN
  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Samara Palma-Milla, MD, PhD · Instituto de Investigación Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2023-07-30
Completion
2023-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486260 on ClinicalTrials.gov