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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Sniffing Stick Smell Test
研究概览
简要总结
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.
详细描述
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:
- Group A (150mg de DMB equivalent to 2, 8 mg of miraculin glycoprotein + 150g of freeze-dried strawberry).
- Group B (300 mg of DMB equivalent to 5, 5 mg of the miraculin glycoprotein).
- Group C (300 mg of strawberry lyophilisate).
Follow up will include 6 individualized visits, to perform the following tests at each visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
- •Withdrawal Criteria:
- •Intolerance to the consumption of DMB or Placebo
结局指标
主要结局
Sniffing Stick Smell Test
时间窗: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
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
Electrogustometry
时间窗: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
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.
Strips' Test
时间窗: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
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.
Taste and Smell Survey
时间窗: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
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).
次要结局
- Body Mass Index (kg/m2)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Albumin serum concentration (g/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Saliva volume (mL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Prealbumin serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Vitamin A serum concentration (μg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Faeces microbiota(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Vitamin B12 serum concentration (pg/mL)(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))
- Up and go test(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Triglycerides serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- LDL-cholesterol serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Vitamin D serum concentration (ng/mL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Weight (kg)(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))
- Glucose serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Total Cholesterol serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- HDL-cholesterol serum concentration (mg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Folic acid serum concentration (ng/mL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Selenium serum concentration (μg/L)(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))
- RCP-us serum concentration (mg/L)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Saliva metagenomics(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Quantitative profile of fatty acids in erythrocytes(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Concentration of 8-hydroxy-2'-deoxyguanosine in urine(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Determination of oxidized and reduced glutathione in erythrocytes(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Vitamin E serum concentration (alfa-tocopherol, μg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Zinc serum concentration (μg/mL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Saliva microbiota(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- SOD superoxide dismutase activity (EC 1.5.1.1)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Iron serum concentration (μg/dL)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Plasma cytokine concentration(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Faeces metagenomics(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Concentration of 8-iso-PGF2α in urine(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Total antioxidant capacity (TAC) of plasma(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Enzyme activity of the antioxidant defense system in erythrocytes(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- CAT catalase activity (EC 1.11.1.6)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Plasma metabolomics(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Glutathione Reductase Activity GR (EC 1.6.4.2)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Fat mass (%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Phase angle (º)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- GPOX glutathione peroxidase activity (EC 1.11.1.9)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Food Frequency Consumption Questionnaire (PREDIMED)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- International Physical Activity Questionnaire (IPAQ)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Quality of Life Questionnaire (EORTIC QLQ-C30)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Muscle mass (%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Body Cell Mass (%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- 72 hour food record questionnaire(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Product Efficacy Satisfaction Questionnaire(Before chemotherapy, After therapy (3-4 days), Follow up (3 months after chemotherapy))
- Extracellular water(%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Intracellular water (%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))
- Total Body Water (%)(Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy))