Nutritional Supplementation in Adults With Chronic Respiratory Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.

Detailed Description
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This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.

Official Title
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Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..

Conditions
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Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Dietary Supplement: Complete enteral formula
* Other: Dietary Advise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 80 years. Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient. Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD). Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men). Patients who signed informed consent. Exclusion Criteria: Clinically unstable patients. Patients requiring other nutritional supplements or parenteral nutrition. Patients diagnosed with active pulmonary tuberculosis. Patients with acute respiratory failure. Patients with immunosuppression (including HIV, diabetes or neoplasms).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitafos<br>Complete enteral formula | Dietary Supplement: Complete enteral formula<br>* Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product). Time of intervention: 3 months.<br>* Other names: Vitafos Vainilla;|
| Active Comparator: Dietary Advise<br>Dietary advise according to the hospital routine clinical practice. | Other: Dietary Advise<br>* Patients will receive the usual dietary advise in these patients according hospital clinical practice .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures. | At hospital discharge or at 1th month and at 3 months | 
| Changes in pulmonary function | Differences in forced expiratory volume measured by spirometry. | At 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Infections | Differences measured by number of infections and hospital readmission rate. | At 1st, 2nd, 3rd month | 
| Muscular Strength | Differences measured by hand-grip strength. | At 3rd month. | 
| Exercise Tolerance | Differences measured by six minutes walk test. | At 3th month | 
| Quality of Life of the participants | Differences measured by Saint George respiratory questionnaire. | At hospital discharge or 1st month and 3rd month | 
| Tolerability of the product | Measured by gastrointestinal discomfort and product compliance. | At 1st, 2nd and 3rd months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD