Malnutrition, Other Pulmonary Disease, Chronic Obstructive, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTComplete enteral formula
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.
OTHERDietary Advise
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
Sponsors
Peruvian Clinical Research
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nutritional status | At hospital discharge or at 1th month and at 3 months | Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures. |
| Changes in pulmonary function | At 3rd month | Differences in forced expiratory volume measured by spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular Strength | At 3rd month. | Differences measured by hand-grip strength. |
| Exercise Tolerance | At 3th month | Differences measured by six minutes walk test. |
| Tolerability of the product | At 1st, 2nd and 3rd months | Measured by gastrointestinal discomfort and product compliance. |
| Quality of Life of the participants | At hospital discharge or 1st month and 3rd month | Differences measured by Saint George respiratory questionnaire. |
| Respiratory Infections | At 1st, 2nd, 3rd month | Differences measured by number of infections and hospital readmission rate. |
Countries
Peru
Outcome results
None listed