Nutritional Supplementation in Adults With Chronic Respiratory Disease (OFOS)
|ClinicalTrials.gov Identifier: NCT02102009|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Pulmonary Disease, Chronic Obstructive Other Pulmonary Disease, Chronic Obstructive||Dietary Supplement: Complete enteral formula Other: Dietary Advise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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..|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Complete enteral formula
Dietary Supplement: Complete 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.
Active Comparator: Dietary Advise
Dietary advise according to the hospital routine clinical practice.
Other: Dietary Advise
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
- Changes in nutritional status [ Time Frame: 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 [ Time Frame: At 3rd month ]Differences in forced expiratory volume measured by spirometry.
- Respiratory Infections [ Time Frame: At 1st, 2nd, 3rd month ]Differences measured by number of infections and hospital readmission rate.
- Muscular Strength [ Time Frame: At 3rd month. ]Differences measured by hand-grip strength.
- Exercise Tolerance [ Time Frame: At 3th month ]Differences measured by six minutes walk test.
- Quality of Life of the participants [ Time Frame: At hospital discharge or 1st month and 3rd month ]Differences measured by Saint George respiratory questionnaire.
- Tolerability of the product [ Time Frame: At 1st, 2nd and 3rd months ]Measured by gastrointestinal discomfort and product compliance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102009
|Clínica San Gabriel|
|San Miguel, Lima, Peru, 2955|
|Principal Investigator:||Marco Antonio Camere Torrealva, Doctor||Clínica San Gabriel - Perú|