CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
DMB lowest dose +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05486260
NCT05486260N/ACompleted

Effect of Regular Consumption of Dried Miracle Berry (DMB) on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial. CLINMIR Pilot Protocol

Instituto de Investigación Hospital Universitario La Paz·interventional·Posted Aug 3, 2022·Updated Aug 15, 2024

In Brief

A clinical study evaluating DMB lowest dose, DMB highest dose, and 1 other intervention for Cancer and 5 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 3, 2022
Enrollment StartJun 23, 2022
Primary CompletionJul 30, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.9 years ago

Interventions

DMB lowest dosedietary

Intake of 150 mg of DMB

DMB highest dosedietary

Intake of 300 mg of DMB

Strawberry lyophilisatedietary

Intake of 300 mg of strawberry lyophilisate