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
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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