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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
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.
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
Clínica San Gabriel
San Miguel, Lima region, Peru
Changes in nutritional status
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Time frame: At hospital discharge or at 1th month and at 3 months
Changes in pulmonary function
Differences in forced expiratory volume measured by spirometry.
Time frame: At 3rd month
Respiratory Infections
Differences measured by number of infections and hospital readmission rate.
Time frame: At 1st, 2nd, 3rd month
Muscular Strength
Differences measured by hand-grip strength.
Time frame: At 3rd month.
Exercise Tolerance
Differences measured by six minutes walk test.
Time frame: At 3th month
Quality of Life of the participants
Differences measured by Saint George respiratory questionnaire.
Time frame: At hospital discharge or 1st month and 3rd month
Tolerability of the product
Measured by gastrointestinal discomfort and product compliance.
Time frame: At 1st, 2nd and 3rd months
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