Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT05486260
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLINMIR
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.
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.
Detailed Description:
Randomized, parallel, triple-blind, controlled clinical trial to evaluate the effect of habitual consumption of DMB on the olfactory-gustative perception in cancer patients with malnutrition.
30 volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: men and women over 18, a weight loss \>=5 %, malnutrition, taste alterations, cancer patients treated with neoadjuvant chemotherapy prior to surgery, chemotherapy or chemo-radiotherapy who are not candidates for surgery, with less than or equal to one third of chemotherapy and/or radiotherapy treatment initially scheduled, a life expectancy greater than 3 months, oral intake of food and drinks, adequate cultural level and understanding of the clinical study.
Participants will be randomized in 3 arms:
1. Group A (150mg de DMB equivalent to 2, 8 mg of miraculin glycoprotein + 150g of freeze-dried strawberry).
2. Group B (300 mg of DMB equivalent to 5, 5 mg of the miraculin glycoprotein).
3. Group C (300 mg of strawberry lyophilisate).
Follow up will include 6 individualized visits, to perform the following tests at each visits:
Selection visit
• Nutritional assessment
• Electrogustometry
• Olfactory-gustative test (test strips)
* Taste and smell survey.
1º visit:
* Measurement of blood pressure and heart rate
* Morphofunctional assessment:
o Anthropometry measures (weight, % weight loss, height, BMI, ICA)
o Bioelectrical impedance (BIA): musculoskeletal mass index (MMI), phase angle (FA), extracellular water (EW), intracellular water (IW) and total water (TBW), fat mass (FM), muscle mass (MM), total cell mass, representation phase angle vector (BIVA)
o Dynamometry
o Nutritional ultrasound
o Functionality test (Up and Go Test)
* Olfactory-gustative test (Sniffin'Stick Smell Test)
* Saliva volume.
* Analytic:
o Biochemistry (albumin, prealbumin, retinol-binding protein (RBP), glucose, lipid profile (Total Cholesterol (TC), triglycerides (TG), HDL, LDL), safety parameters (transaminases, urate, creatinine), fat-soluble vitamins (A, D, E), B12, folate, iron metabolism, Zn, Se. Hemogram, lymphocytes, coagulation, hsCRP)
o Stool microbiota and metagenome
o Saliva microbiota and metagenome
o Plasma metabolomes
o Quantitative profile of fatty acids in erythrocytes (enzymatic activity of catalase (CAT), superoxide dismutase (SOD), glutathione-reductase (GR) and glutathione peroxidase (GPOX))
o Plasma cytokine profile (Interleukin (IL) 1β, 4, 6, 8, 10 tumor necrosis factor (TNFα), interferon γ (IFNγ), sIL6R, sTNFR)
o Metabolites in urine
o System status of antioxidant status (hydroxyguanosine and F2-Isoprostanes)
2º visit:
* Anthropometric measures
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (post-QTx)
3º and 4º visit:
* Morphofunctional assessment:
* Measurement of blood pressure and heart rate,
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (pre-QTx)
* Analytic:
o Biochemistry
o Stool microbiota and metagenome (v3)
o Saliva microbiota and metagenome
o Plasma metabolomes
o Quantitative profile of fatty acids in erythrocytes
o Plasma cytokine profile
o Metabolites in urine
o System status of antioxidant status
5º visit:
* Morphofunctional assessment:
* Measurement of blood pressure and heart rate,
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (pre-QTx)
* Analytic:
o Biochemistry
o Stool microbiota and metagenome (v3)
* Saliva microbiota and metagenome
* Plasma metabolomes
* Quantitative profile of fatty acids in erythrocytes
* Plasma cytokine profile
* Metabolites in urine
* System status of antioxidant status
30 volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: men and women over 18, a weight loss \>=5 %, malnutrition, taste alterations, cancer patients treated with neoadjuvant chemotherapy prior to surgery, chemotherapy or chemo-radiotherapy who are not candidates for surgery, with less than or equal to one third of chemotherapy and/or radiotherapy treatment initially scheduled, a life expectancy greater than 3 months, oral intake of food and drinks, adequate cultural level and understanding of the clinical study.
Participants will be randomized in 3 arms:
1. Group A (150mg de DMB equivalent to 2, 8 mg of miraculin glycoprotein + 150g of freeze-dried strawberry).
2. Group B (300 mg of DMB equivalent to 5, 5 mg of the miraculin glycoprotein).
3. Group C (300 mg of strawberry lyophilisate).
Follow up will include 6 individualized visits, to perform the following tests at each visits:
Selection visit
• Nutritional assessment
• Electrogustometry
• Olfactory-gustative test (test strips)
* Taste and smell survey.
1º visit:
* Measurement of blood pressure and heart rate
* Morphofunctional assessment:
o Anthropometry measures (weight, % weight loss, height, BMI, ICA)
o Bioelectrical impedance (BIA): musculoskeletal mass index (MMI), phase angle (FA), extracellular water (EW), intracellular water (IW) and total water (TBW), fat mass (FM), muscle mass (MM), total cell mass, representation phase angle vector (BIVA)
o Dynamometry
o Nutritional ultrasound
o Functionality test (Up and Go Test)
* Olfactory-gustative test (Sniffin'Stick Smell Test)
* Saliva volume.
* Analytic:
o Biochemistry (albumin, prealbumin, retinol-binding protein (RBP), glucose, lipid profile (Total Cholesterol (TC), triglycerides (TG), HDL, LDL), safety parameters (transaminases, urate, creatinine), fat-soluble vitamins (A, D, E), B12, folate, iron metabolism, Zn, Se. Hemogram, lymphocytes, coagulation, hsCRP)
o Stool microbiota and metagenome
o Saliva microbiota and metagenome
o Plasma metabolomes
o Quantitative profile of fatty acids in erythrocytes (enzymatic activity of catalase (CAT), superoxide dismutase (SOD), glutathione-reductase (GR) and glutathione peroxidase (GPOX))
o Plasma cytokine profile (Interleukin (IL) 1β, 4, 6, 8, 10 tumor necrosis factor (TNFα), interferon γ (IFNγ), sIL6R, sTNFR)
o Metabolites in urine
o System status of antioxidant status (hydroxyguanosine and F2-Isoprostanes)
2º visit:
* Anthropometric measures
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (post-QTx)
3º and 4º visit:
* Morphofunctional assessment:
* Measurement of blood pressure and heart rate,
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (pre-QTx)
* Analytic:
o Biochemistry
o Stool microbiota and metagenome (v3)
o Saliva microbiota and metagenome
o Plasma metabolomes
o Quantitative profile of fatty acids in erythrocytes
o Plasma cytokine profile
o Metabolites in urine
o System status of antioxidant status
5º visit:
* Morphofunctional assessment:
* Measurement of blood pressure and heart rate,
* Electrogustometry
* Olfactory-gustative test
* Saliva volume
* Taste and smell survey
* Product efficacy satisfaction questionnaire (pre-QTx)
* Analytic:
o Biochemistry
o Stool microbiota and metagenome (v3)
* Saliva microbiota and metagenome
* Plasma metabolomes
* Quantitative profile of fatty acids in erythrocytes
* Plasma cytokine profile
* Metabolites in urine
* System status of antioxidant status
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: