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

NCT05486260 | Completed

• 1 other identifier: HULP 6164
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Electrogustometry

  In this test, perception thresholds are obtained by electrical stimulation (current in microamperes), administered in different tongue regions through small disc-shaped monopolar electrodes.Three areas of the tongue (fenced papillae, tongue apex, and soft palate) are stimulated on both the right and left sides in ascending order two at a time from -6 dB (4 mA) to 34 dB (400 mA). ) in intervals of 0.5, 1, 1.5 and 2 s. If the stimulus is not detected, a single stimulus will be performed at 36 dB and another at -6 dB, to which the subject must answer whether or not they have been able to detect the stimulus.

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Sniffing Stick Smell Test

  Sniffing Sticks are markers filled with an odorous fragrance that when removed from the stick releases the smell.To perform all tests, the open pen is held approximately 2 cm in front of the nostrils and the subject is verbally warned to smell it (for example, by saying the number on the pen). The pens are labeled with red numbers from 1 to 16. If the patient hits less than 8 smells, it is considered that they have altered taste and smell

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Strips' Test

  Test for the identification of taste deficiencies validated. This test uses spoon-shaped flavor-impregnated filter papers that allow them to be selectively applied to specific areas of the tongue. In this test, 4 flavors (sweet, salty, bitter and acid) are evaluated at 4 different concentrations. The sweet taste will be represented by sucrose (0.4, 0.02, 0.1, 0.05 g/mL), the acid by citric acid (0.3, 0.16, 0.09, 0.05 g/mL), the balance by sodium chloride (0.25, 0.1, 0.004, 0.016 g/dL) and quinine bitter (0.006, 0.0024, 0.0009, 0.0004 g/dL). A 1 is marked if the flavor is detected and a 0 if it is not detected. To obtain the global impression of the taste function, a taste score is performed based on the minimum concentration detected and the flavor used.

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Taste and Smell Survey

  This test is used to explore the prevalence, characteristics, and severity of taste and smell changes in a disease. It is made up of 12 items, 7 of them related to taste and 5 related to smell. For each of the questions, 1 point will be assigned for each question answered negatively. An additional point will be awarded for mild/moderate or rarely/sometimes and 2 points for severe/disabling or often/always. Changes in taste were scored from 0 (no change) to 10 (multiple severe changes) and changes in smell from 0 (no change) to 5 (multiple severe changes).

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

Secondary Outcomes (51)

• Weight (kg)

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Waist circumference (cm)

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Body Mass Index (kg/m2)

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Manual dynamometry

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

• Muscle ultrasound

  Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)

Study Arms (3)

Group A

EXPERIMENTAL

Pills with 300 mg of DMB equivalent to 5,5 mg of the miraculin glycoprotein

Dietary Supplement: DMB highest dose

Group B

EXPERIMENTAL

Pills with 150 mg of DMB equivalent to 2,8 mg of miraculin glycoprotein + 150g of freeze-dried strawberry

Dietary Supplement: DMB lowest dose

Group C

PLACEBO COMPARATOR

Pills with 300 mg of strawberry lyophilisate

Dietary Supplement: Strawberry lyophilisate

Interventions

DMB lowest dose DIETARY_SUPPLEMENT

Intake of 150 mg of DMB

Also known as: Experimental 1

Group B

DMB highest dose DIETARY_SUPPLEMENT

Intake of 300 mg of DMB

Also known as: Experimental 2

Group A

Strawberry lyophilisate DIETARY_SUPPLEMENT

Intake of 300 mg of strawberry lyophilisate

Also known as: Placebo comparator

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18
• Patients with a weight loss \>=5 %
• Patient with malnutrition assessed by Global Leadership Initiative on Malnutrition (GLIM) Criteria
• Patients with taste alterations measured by electrogustometry
• Cancer patients treated with neoadjuvant chemotherapy prior to surgery, chemotherapy or chemo-radiotherapy who are not candidates for surgery.
• Patients with less than or equal to one third of chemotherapy and/or radiotherapy treatment initially scheduled.
• Patients with a life expectancy greater than 3 months.
• Patient with oral intake of food and drinks.
• Adequate cultural level and understanding of the clinical study.
• Agree to voluntarily participate in the study and give their signed written informed consent.

You may not qualify if:

• Patients who are participating in other clinical trials.
• Patients with a weight loss \< 5%
• Patients with a parenteral o enteral nutrition
• Patients diagnosed with poorly controlled Diabetes Mellitus (HbA1 c\>8%)
• Patients with uncontrolled high blood pressure.
• Patients with uncontrolled hyper/hypothyroidism.
• Patients with severe digestive toxicity due to treatment with chemo-radiotherapy
• Patients with a life expectancy of less than 3 months.
• Patients diagnosed with severe kidney or liver disease (chronic kidney failure, nephrotic syndrome, cirrhosis).
• Patients with severe dementia, brain metastases, eating behavior disorders, history of serious neurological or psychiatric pathology that may interfere with treatment.
• Patients suffering from alcoholism or substance abuse that may interfere with adherence to treatment.
• Patients with serious gastrointestinal diseases.
• Patients who reject the consumption of DMB.
• Pregnant or lactating women.
• Assessment that, in the clinician's opinion, prevents the patient from participating (severity, etc.)

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator
• Medicinal Gardens S.L: collaborator

Study Sites (1)

Bricia LOPEZ PLAZA

Madrid, 28012, Spain

Location

Related Publications (3)

• Lopez-Plaza B, Gil A, Menendez-Rey A, Bensadon-Naeder L, Hummel T, Feliu-Batlle J, Palma-Milla S. 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. Nutrients. 2023 Nov 1;15(21):4639. doi: 10.3390/nu15214639.

  PMID: 37960292 RESULT

• Alvarez-Mercado AI, Lopez-Plaza B, Plaza-Diaz J, Arcos-Castellanos L, Ruiz-Ojeda FJ, Brandimonte-Hernandez M, Feliu-Batlle J, Hummel T, Palma-Milla S, Gil A. Miraculin Can Contribute to a Reduction in Inflammatory Biomarkers and Cachexia in Malnourished Patients with Cancer and Taste Disorders. Pharmaceuticals (Basel). 2025 Apr 25;18(5):622. doi: 10.3390/ph18050622.

  PMID: 40430444 DERIVED

• Lopez-Plaza B, Alvarez-Mercado AI, Arcos-Castellanos L, Plaza-Diaz J, Ruiz-Ojeda FJ, Brandimonte-Hernandez M, Feliu-Batlle J, Hummel T, Gil A, Palma-Milla S. Efficacy and Safety of Habitual Consumption of a Food Supplement Containing Miraculin in Malnourished Cancer Patients: The CLINMIR Pilot Study. Nutrients. 2024 Jun 17;16(12):1905. doi: 10.3390/nu16121905.

  PMID: 38931260 DERIVED

MeSH Terms

Conditions

Neoplasms; Dysgeusia; Ageusia; Malnutrition

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Samara Palma-Milla, MD, PhD

  Instituto de Investigación Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 3, 2022
• Study Start: June 23, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 15, 2024

Record last verified: 2023-05

Locations

ES (1)